MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-02-22 for SWANSON WRIST JOINT IMPLANT G488-0205 manufactured by Wright Medical Technology, Inc..
| Report Number | 1043534-2001-00040 |
| MDR Report Key | 317185 |
| Report Source | 06 |
| Date Received | 2001-02-22 |
| Date of Event | 2000-12-28 |
| Date Reported to Mfgr | 2001-01-22 |
| Date Mfgr Received | 2001-01-22 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 2001-02-27 |
| 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 | 0 |
| Manufacturer Contact | DEBBY DAURER |
| Manufacturer Street | 5677 AIRLINE RD |
| Manufacturer City | ARLINGTON TX 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674601 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWANSON WRIST JOINT IMPLANT |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | KIG |
| Date Received | 2001-02-22 |
| Model Number | NA |
| Catalog Number | G488-0205 |
| Lot Number | 126A054325 |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 306717 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| 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 | G488-0205 |
| 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 | 2001-02-22 |