MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-09 for ILIAC CREST * 1CW2R manufactured by Life Net.
[351754]
Iliac crest placed in 2004. Pt returned to surgery in 3 months and the graft was crushed. Graft site was c6-c7. Requested removal and fusion collapsed disc replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033518 |
| MDR Report Key | 551947 |
| Date Received | 2004-09-09 |
| Date of Report | 2004-09-09 |
| Date of Event | 2004-06-07 |
| Date Added to Maude | 2004-10-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | ILIAC CREST |
| Generic Name | BONE GRAFT |
| Product Code | LMO |
| Date Received | 2004-09-09 |
| Model Number | * |
| Catalog Number | 1CW2R |
| Lot Number | 032980027 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 541475 |
| Manufacturer | LIFE NET |
| Manufacturer Address | 1 GATEWAY CENTER STE 202 NEWTON MA 02458 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-09 |