MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for ZYPPAH SNORING APPLIANCE manufactured by Zyppah, Inc..
[178570707]
Permanently misaligned jaw. I have used the zyppah snoring appliance for several years. I have recently been diagnosed (by both prosthodontist and orthodontist) with a serious misalignment of jaw caused by extended use of this device. Both upper and lower teeth have shifted and jaw has move forward. It now requires extensive orthodontia to fix to prevent even more extensive damage to my teeth long term due to misaligned bite. Hcps report that this is a known issue with this product and others like it, yet there are no safety warnings to prevent other consumers form being similarly harmed. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092870 |
| MDR Report Key | 9686779 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-05 |
| Date Added to Maude | 2020-02-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYPPAH SNORING APPLIANCE |
| Generic Name | DEVICE, ANTI-SNORING |
| Product Code | LRK |
| Date Received | 2020-02-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZYPPAH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |