MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for TOTAL TMJOINT REPLACEMENT manufactured by Unk.
[60665986]
Tmj implant total joint replacement in (b)(6). Chromium. Cobalt molyb. Used in left side of jaw. Major ongoing medical problems including inflammation throughout body. Severe pain, and bone loss in area. Severe pain in neck, fatigue, left eye problem, feeling of illness constantly. Fifth surgery after having had a vitek implant after a basketball injury to jaw. Numerous problems following that first surgery. Corrective surgeries performed over years. Questions of metal allergies without determination. Family doctors do not want to be involved. Neurologist says not enough info on subject. No remaining surgeries that they can do to decrease pain, bone loss, and other devastating physical problems. Disability in questions due to little updated info on these implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066201 |
| MDR Report Key | 6116522 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-11-17 |
| Date Added to Maude | 2016-11-21 |
| 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 | UNKNOWN |
| 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 | TOTAL TMJOINT REPLACEMENT |
| Generic Name | TMJOINT |
| Product Code | MPI |
| Date Received | 2016-11-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 81 | 1. Deathisabilit | 2016-11-17 |