MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-17 for ALTA 4 HOLE BROAD PLATE 5215-0-004 manufactured by Stryker Trauma Selzach Ag.
[20243552]
It was reported through the filing of a law suit that allegedly device was negligently installed in plaintiffs leg in 2001 requiring revision 4 months later. It is further alleged that the "thin part" of the broad plate had a crack with a slight bend at the end. Additionally, it is alleged that the "plate coupler" has a crack of approximately 1/2" long.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031020-2002-00008 |
| MDR Report Key | 422744 |
| Date Received | 2002-10-17 |
| Date of Report | 2002-09-20 |
| Date Mfgr Received | 2002-09-20 |
| Date Added to Maude | 2002-10-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROSE MINCIELI |
| Manufacturer Street | 359 VETERANS BLVD |
| Manufacturer City | RUTHERFORD NJ 07070 |
| Manufacturer Country | US |
| Manufacturer Postal | 07070 |
| Manufacturer Phone | 2015077308 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTA 4 HOLE BROAD PLATE |
| Generic Name | IMPLANT |
| Product Code | KIT |
| Date Received | 2002-10-17 |
| Model Number | NA |
| Catalog Number | 5215-0-004 |
| Lot Number | BZHWW |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 411797 |
| Manufacturer | STRYKER TRAUMA SELZACH AG |
| Manufacturer Address | BOHNACKERWEG 1 SELZACH SZ 2545 |
| Baseline Brand Name | ALTA 4 HOLE BROAD PLATE |
| Baseline Generic Name | FRACTURE FIXATION DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 5215-0-004 |
| Baseline ID | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K850442 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-17 |