MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-09-17 for K-WIRES 5300-006-045 NA manufactured by Stryker Instruments.
[302172]
Infection at k wire sites were documented by the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616696-2003-00006 |
| MDR Report Key | 483877 |
| Report Source | 06 |
| Date Received | 2003-09-17 |
| Date of Report | 2003-08-14 |
| Report Date | 2003-08-14 |
| Date Mfgr Received | 2003-08-14 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2003-09-23 |
| 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 Street | 4100 E MILHAM AVE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-WIRES |
| Generic Name | WIRE, FIXATION, INTRAOSSEOUS |
| Product Code | DZK |
| Date Received | 2003-09-17 |
| Model Number | 5300-006-045 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 472763 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E MILHAM AVE KALAMAZOO MI 49001 US |
| Baseline Brand Name | K-WIRES |
| Baseline Generic Name | WIRE, FIXATION, INTRAOSSEOUS |
| Baseline Model No | 5300-006-045 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | STAINLESS STEEL K-WIRES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-17 |