MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-10-15 for TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEMS NA NA FEL KIT FER KIT manufactured by Tmj Implants, Inc..
[135455]
Surgeon called to discuss pt's symptoms of itching and pain. The co. Offered to send the physician sensitivity patch tests for the pt. In 1999 the surgeon explanted the devices. At that time, no tissue samples were taken and no allergy testing was done. The surgeon stated the pt was found to have fibrous tissue, but did not have any other abnormal findings. Subsequent follow-up with surgeon revealed the itching symptoms resolved. The pt was still experiencing pain which the surgeon stated was due to adhesions from previous surgeries. Eval of the devices reveals typical wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721760-1999-00026 |
| MDR Report Key | 244750 |
| Report Source | 05 |
| Date Received | 1999-10-15 |
| Date of Report | 1999-09-13 |
| Date of Event | 1999-09-13 |
| Date Facility Aware | 1999-09-13 |
| Report Date | 1999-09-13 |
| Date Mfgr Received | 1999-09-13 |
| Device Manufacturer Date | 1996-11-01 |
| Date Added to Maude | 1999-10-18 |
| 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 |
| Manufacturer Contact | JAMES MORGAN |
| Manufacturer Street | 17301 W. COLFAX AVE STE 135 |
| Manufacturer City | GOLDEN CO 80401 |
| Manufacturer Country | US |
| Manufacturer Postal | 80401 |
| Manufacturer Phone | 3032771338 |
| Manufacturer G1 | TMJ IMPLANTS, INC. |
| Manufacturer Street | 17301 W. COLFAX AVE STE 135 |
| Manufacturer City | GOLDEN CO 80401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80401 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEMS |
| Generic Name | TEMPOROMANDIBULAR JOINT PROSTHESIS SYSTEMS |
| Product Code | JAZ |
| Date Received | 1999-10-15 |
| Returned To Mfg | 1999-10-04 |
| Model Number | NA NA |
| Catalog Number | FEL KIT FER KIT |
| Lot Number | 2166 4031 |
| ID Number | NA NA |
| Device Expiration Date | 2000-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 237117 |
| Manufacturer | TMJ IMPLANTS, INC. |
| Manufacturer Address | 17301 WEST COLFAX AVE., SUITE 135 GOLDEN CO 80401 US |
| Baseline Brand Name | TMJ FOSSA- EMINENCE & CONDYLAR PROSTHESIS SYSTEM |
| Baseline Generic Name | FOSSA-EMINENCE AND CONDYLAR PROSTHESIS |
| Baseline Model No | NA NA |
| Baseline Catalog No | FEL KIT R/LCP KIT |
| Baseline ID | NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-10-15 |