MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-02 for SWANSON WRIST JOINT G488-0203 * manufactured by Wright Medical.
[20934017]
Right wrist implant failure; implant fractured requiring surgery to replace.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 267036 |
MDR Report Key | 267036 |
Date Received | 2000-03-02 |
Date of Report | 2000-01-28 |
Date of Event | 2000-01-25 |
Date Facility Aware | 2000-01-26 |
Report Date | 2000-01-28 |
Date Reported to Mfgr | 2000-01-28 |
Date Added to Maude | 2000-03-07 |
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 |
Reporter Occupation | RISK MANAGER |
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 | SWANSON WRIST JOINT |
Generic Name | WRIST JOINT |
Product Code | KIG |
Date Received | 2000-03-02 |
Model Number | G488-0203 |
Catalog Number | * |
Lot Number | 114A009551 |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 4 YR |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 1 |
Device Event Key | 258507 |
Manufacturer | WRIGHT MEDICAL |
Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US |
Baseline Brand Name | SWANSON WRIST JOINT IMPLANT |
Baseline Generic Name | SMALL JOINT COMPONENT |
Baseline Model No | NA |
Baseline Catalog No | G488-0203 |
Baseline ID | NA |
Baseline Device Family | S J 888.3780 |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K850255 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2000-03-02 |