MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-03 for TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM FEL KIT FER-KIT R/LCP-KIT manufactured by Tmj Implants, Inc..
[131381]
Devices explanted due to pain, muscle spasms, and extensive wear on acrylic condylar heads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721760-1999-00017 |
| MDR Report Key | 225967 |
| Report Source | 05 |
| Date Received | 1999-06-03 |
| Date of Report | 1999-05-03 |
| Date of Event | 1999-04-22 |
| Report Date | 1999-05-03 |
| Date Reported to Mfgr | 1999-05-03 |
| Date Mfgr Received | 1999-05-03 |
| Device Manufacturer Date | 1993-12-01 |
| Date Added to Maude | 1999-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM |
| Generic Name | TEMPORMANDIBULAR JOINT PROSTHESIS SYSTEMS |
| Product Code | JAZ |
| Date Received | 1999-06-03 |
| Returned To Mfg | 1999-04-26 |
| Model Number | NA |
| Catalog Number | FEL KIT FER-KIT R/LCP-KIT |
| Lot Number | L-(0022)R-(0033) R/LCP(MORE) |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | Y |
| Device Sequence No | 1 |
| Device Event Key | 219136 |
| Manufacturer | TMJ IMPLANTS, INC. |
| Manufacturer Address | 17301 W. COLFAX AVE. SUITE 135 GOLDEN CO 80401 US |
| Baseline Brand Name | TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM |
| Baseline Generic Name | TEMPORMANDIBULAR JOINT PROSTHESIS SYSTEMS |
| Baseline Model No | NA |
| Baseline Catalog No | FEL KIT FER-KIT R/LCP-KIT |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-03 |