MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-06 for TMJ FOSSA EMINENCE PROSTHESIS manufactured by Nexus Cmf, Llc.
[59495352]
I received nexus cmf implant to my left tmj for ear pain. Continued to have worsening pain. Surgeon placed it despite warning letter from fda. Now have to have surgery out of both my joints due to increase pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065871 |
| MDR Report Key | 6085359 |
| Date Received | 2016-11-06 |
| Date of Report | 2016-11-06 |
| Date of Event | 2015-09-29 |
| Date Added to Maude | 2016-11-08 |
| 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 | 0 |
| Brand Name | TMJ FOSSA EMINENCE PROSTHESIS |
| Generic Name | TMJ FOSSA EMINENCE PROSTHESIS |
| Product Code | MPI |
| Date Received | 2016-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEXUS CMF, LLC |
| Manufacturer Address | 17301 W. COFFAX AVE STE 170 GOLDEN CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-11-06 |