MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-11 for SILICONE LUNATE IMPLANT NI manufactured by Unknown.
[9178]
Pt demonstrated almost complete volar subluxation of the lunate implant on preoperative tomography, impingement of the scaphoid in the scaphoid fossa, and proximal migration of the carpal capitate. At surgery, implant was intact, but had an egg-yellow color and was much softer than normal. Findings consistent with possible silicone synovitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 14127 |
| MDR Report Key | 14127 |
| Date Received | 1994-04-11 |
| Date of Report | 1994-04-04 |
| Date of Event | 1994-02-07 |
| Date Facility Aware | 1994-02-07 |
| Report Date | 1994-04-04 |
| Date Reported to FDA | 1994-04-04 |
| Date Added to Maude | 1994-06-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE LUNATE IMPLANT |
| Generic Name | SILICONE LUNATE IMPLANT |
| Product Code | KWN |
| Date Received | 1994-04-11 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 10 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 14124 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-11 |