MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-12-17 for AMC WRIST 6440-5-002 manufactured by Howmedica Inc..
| Report Number | 2219689-1998-00706 |
| MDR Report Key | 202751 |
| Report Source | 07 |
| Date Received | 1998-12-17 |
| Date of Report | 1998-12-16 |
| Date of Event | 1998-07-31 |
| Date Mfgr Received | 1998-11-24 |
| Date Added to Maude | 1998-12-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMC WRIST |
| Generic Name | IMPLANT |
| Product Code | KWN |
| Date Received | 1998-12-17 |
| Model Number | NA |
| Catalog Number | 6440-5-002 |
| Lot Number | KGZHA |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 192501 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD RUTHERFORD NJ 07070 US |
| Baseline Brand Name | AMC WRIST |
| Baseline Generic Name | ARTIFICIAL WRIST COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6440-5-002 |
| Baseline ID | NA |
| Baseline Device Family | METACARPAL SOMPONENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K790793 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-17 |