MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-14 for 12-2082 manufactured by Smith And Nephew Richards.
[16275172]
Status post fracture of right femur. Nail implanted 6 wks ago. Removed 12/1/93 due to failure to heal. Pt had troximal displacement of fracture with failure of internal fixation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 12173 |
| MDR Report Key | 12173 |
| Date Received | 1994-01-14 |
| Date of Report | 1993-12-02 |
| Date of Event | 1993-12-01 |
| Date Facility Aware | 1993-12-01 |
| Report Date | 1993-12-02 |
| Date Reported to Mfgr | 1993-12-06 |
| Date Added to Maude | 1994-03-23 |
| 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 |
| 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 |
| Generic Name | RUSSELL-TAYLOR NAIL |
| Product Code | KTN |
| Date Received | 1994-01-14 |
| Catalog Number | 12-2082 |
| Lot Number | 2C91365, 2C93825 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 12173 |
| Manufacturer | SMITH AND NEPHEW RICHARDS |
| Manufacturer Address | MEMPHIS TN 381161804 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Hospitalization; 2. Required No Informationntervention | 1994-01-14 |