MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-05 for * TAYLOR SPATIAL FRAME STRUTS manufactured by Smith & Nephew Richard, Inc..
[310093]
Orthopaedic spatial fram with struts. Struts failed - 2 out of 6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031444 |
| MDR Report Key | 515962 |
| Date Received | 2004-03-05 |
| Date of Report | 2004-03-04 |
| Date Added to Maude | 2004-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | STRUTS |
| Product Code | IQO |
| Date Received | 2004-03-05 |
| Returned To Mfg | 2004-02-01 |
| Model Number | TAYLOR SPATIAL FRAME STRUTS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 504977 |
| Manufacturer | SMITH & NEPHEW RICHARD, INC. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-05 |