MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-28 for TIE-IN? 8563002 manufactured by Wright Medical Technology, Inc..
[137418278]
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
[137418279]
Allegedly, the trapezium implant broke in two places in the patients wrist. Patient underwent a revision surgery.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1043534-2019-00018 |
MDR Report Key | 8378358 |
Report Source | CONSUMER |
Date Received | 2019-02-28 |
Date of Report | 2019-01-30 |
Date of Event | 2018-10-15 |
Date Mfgr Received | 2019-01-30 |
Device Manufacturer Date | 2016-03-31 |
Date Added to Maude | 2019-02-28 |
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 | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR MATTHEW PARRISH |
Manufacturer Street | 1023 CHERRY RD |
Manufacturer City | MEMPHIS TN 38117 |
Manufacturer Country | US |
Manufacturer Postal | 38117 |
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? |
Generic Name | PROSTHESIS, WRIST, CARPAL TRAPEZIUM |
Product Code | KYI |
Date Received | 2019-02-28 |
Model Number | 8563002 |
Lot Number | 1574278 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
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 | 1. Required No Informationntervention | 2019-02-28 |