Remake Cases

Remake cases have returned to NEOLab, either for repair, because the case was made incorrectly, or because the patient needs a duplicate (i.e. lost retainer). Because these cases require a bit more attention, they contain extra fields with more information. 

This article will cover only the additional fields present on a Remake / Repair case on desktop. For the full explanation of the Case Edit Page and the Case Review Page, please see the linked articles. 

TABLE OF CONTENTS

• Completing Remake Fields 
• Identifying Remake Cases 
• Remake Notes
• Prescription Comparison Tabs

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Completing Remake Fields 

We may receive a remake case in a number of different ways, whether it's as a returned appliance, initiated as a phone call, or by receiving a new prescription with notes about a remake. In any case, we must mark the case as a remake, and fill out fields that collect data on what went wrong. 

Remake cases will feature an additional section over New cases, and will collect information relevant to the reported issue. These fields include connection to the original case, the reason for failure, any discount, who was at fault, remake notes, and various FDA-governed fields. 

Field	Action
Original Case #	Remake cases are returning to the lab. Enter the original case number in this field to tie this new case to the old one.
Reason	There are a number of preloaded reasons that something might have gone wrong with the case. After reading notes, or discussing the case with the office, select the remake reason that best applies to this case: Reason Use Case Acrylic fracture The acrylic component broke.  Band failure The band itself broke, or in some other way disconnected from the appliance.  Bands too large Bands the lab fit were too large to seat. Bands too small Bands the lab fit were too small to seat.  Blockout issue The lab applied too much or too little blockout to a model. This made the appliance too loose to fit and stay in, or too tight to get into the mouth and/or comfortably remove. This is commonly an issue when blocking out for nightguards or essix retainers that have FLRs.  Defective mechanism Some functional component of the appliance would not work.  A common example is that a screw would not turn.  Distorted impression The doctor sent an impression, model, or scan, that was not true to patient anatomy. The case fit the model provided, but not the impression.  Dr changed RX The doctor changed their mind about what features this appliance needed to have.  Essix Failure The essix cracked, or broke.  Incorrect Scan Pulled The lab incorrectly added the wrong patient scan to the case.  Lab Error The lab made some error that caused this appliance to fail.  Laser Weld Failure The welding broke between the band and the appliance, or between components of the appliance. Patient Error The patient lost and/or broke the appliance due to misuse. A common scenario is patients chewing gum or other prohibited foods and damaging an appliance.  Poor Fit The appliance did not fit the patient well enough to use.  Removable Repair A removable device needs a repair of some sort, whether it is a cosmetic fix or a broken component.  Removable Wire Failure The labial bow or clasping broke on a removable appliance.  Reorder This appliance is being reordered exactly the same as the previous version, whether it was lost, broken, or the patient needs a duplicate.  RX Error There was an error made on the prescription. This may be from the doctor selecting the wrong options, or from NEOLab providing an incorrect prescription option.  UPS Lost Package UPS lost the package, and the appliance was either severely delayed or not delivered at all.  Wire error There was an issue with the wire on the appliance, whether fixed or removable. This might be used when the wire has broken due to a manufacturing error.
Discount for Remake/Repair	Select the discount that should apply to this remake. While this will vary case by case, in general, cases that receive a 100% discount are fully remade without charge because of some error that was not the doctor's fault (manufacturing or shipping errors). Cases that receive a 0% discount are full charge because they were the doctor or patient's fault (patient lost retainer or the doctor changed their mind).
Remake/repair Fault	After reading notes, or discussing the case with the office, select the fault reason that best applies to this case: Fault  Use Case Lab error NEOLab manufactured the case incorrectly, or missed something on the script or in design instructions.  Doctor error The case was completed as ordered, but the doctor wanted additional or different features they did not describe. This might also be used in cases where the doctor chose the wrong items on the original prescription.  Patient error The patient lost or broke the appliance.  UPS error  UPS lost the package, misdelivered, or heavily delayed the delivery to where the device had to be remade in order to keep the patient appointment.  Nobody error There was no clear fault for this remake.
Complaint type	Not all received remakes are considered true complaints in the eyes of the FDA. Select the type of complaint that applies to this case: Complaint Type Use Case Device Failure The device did not accomplish it's intended goal. For example, an RPE did not expand, or did not work toward expansion (broken mechanism or other issue).  Labeling Failure The case was labeled incorrectly, and it caused the doctor or patient to be confused or use the appliance incorrectly. For example, an RPE for Johnny Smith was labeled with a hawley label for Sally Thomas. This might also apply to instructions provided with the device, that were either unclear or led the user to misuse the appliance, causing an issue for the patient.  Packaging Failure  The packaging did not protect the appliance on the way back to the office, under normal shipping and handling conditions. For example, a new type of shipping box was crushed on arrival and the appliances inside damaged.  Other If none of the scenarios above match the scenario of this complaint, select "other". This will include things like lost retainers or changed prescriptions, which do not constitute "true" complaints under FDA descriptions.
MDR Event	An MDR (Medical Device Reportable) event is one in which a patient is seriously injured or killed, and the appliance is suspected to have contributed. The risk of an MDR event occurring is exceptionally low at NEOLab.  This is a major issue, and one that puts NEOLab under much stricter reporting deadlines. in the event that any of the following criteria have been met, check the checkbox and immediately inform a member of the compliance team:  A patient has died, and death is linked to the use of the appliance; A patient has been seriously injured by a device, and medical remediation (i.e. surgery or another similarly serious procedure) was needed to correct the issue.
Escalate to Investigation	This checkbox should be clicked when: There is a major manufacturing issue that needs to be investigated to ensure it does not happen again. This might be something like screws falling apart while in use, or back-turning and failing to expand.  There is a recurrent issue that needs to be addressed. This might be something like a number of cases being received with moldy acrylic. These cases would be investigated to determine if they were from the same batch, or if there was a deeper ongoing issue that needs to be resolved to protect other patients ordering this appliance.
Investigation Notes	This field will appear when the "Escalate to Investigation" checkbox is clicked. You should not need to complete this field. Rather, it will be used by team members who are investigating the issue to find a root cause.
Remake/repair notes	Add any notes that are relevant to the remake case. This might include notes from conversations with the doctor or other information learned about this particular case and the reason it's being remade.

Identifying Remake Cases 

Remake/ repair cases both contain additional icons to help users quickly understand what type of case they're working on. The wrench icon indicates this case either needs to be fixed or corrected. 

Remake Notes

Remake cases feature dedicated a Remake Notes section. This field is completed by the doctor as they submit the case, or by the NEOLab team member checking the case in. Sometimes, doctor notes help to explain what happened with the case, and what went wrong. In the example below, the patient broke the appliance, meaning we'll remake the case, but at full price. 

Sometimes, these notes are omitted by the doctor, and so the NEOLab team member dealing with the case will include any notes that are relevant from their conversation with the doctor. In this example, the doctor didn't include any notes, but one of the Customer Service Representatives spoke with the office and got more information. This is helpful in understanding what went wrong with the original case. 

In both cases, we can see the reported reason for the remake or repair, what discount the case is being given, and who was at fault for the issue. Generally, if the lab is at fault, the remake is provided at no charge (100% discount). 

Prescription Comparison Tabs

The other major difference is found in the Prescription section. In a remake case, there is a toggle that allows a user to switch between the original prescription and the remake. This is useful in comparing the reason for a remake, or in highlighting what was missed by the lab in the original prescription.

Most often, the original and new prescription are identical, or very similar, but occasionally, a doctor will totally change their design or even appliance.