MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-09-07 for TIE-IN(R) 8563002 manufactured by Wright Medical Technology, Inc..
[119514379]
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[119514380]
Translated: silicone prosthesis is broken, was only implanted last year pat. Was operated again today, because you had to remove the prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00092 |
| MDR Report Key | 7855053 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-07 |
| Date of Event | 2018-06-28 |
| Date Facility Aware | 2018-07-04 |
| Date Mfgr Received | 2018-07-04 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2018-09-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1023 CHERRY ROAD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 9014516318 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIE-IN(R) |
| Generic Name | PROSTHESIS, WRIST, CARPAL TRAPEZIUM |
| Product Code | KYI |
| Date Received | 2018-09-07 |
| Returned To Mfg | 2018-09-01 |
| Model Number | 8563002 |
| Lot Number | 1584897 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |