MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-05 for manufactured by Zimmer Orthopaedics Surgical Pr.
| Report Number | 1035617-2007-00002 |
| MDR Report Key | 977860 |
| Report Source | 05 |
| Date Received | 2007-10-05 |
| Date of Report | 2007-09-05 |
| Date Facility Aware | 2007-09-05 |
| Report Date | 2007-09-05 |
| Date Mfgr Received | 2007-09-05 |
| Date Added to Maude | 2008-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOYCE ELKINS |
| Manufacturer Street | 200 WEST OHIO AVE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | ILZ |
| Date Received | 2007-10-05 |
| Catalog Number | NI |
| Lot Number | NA |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 880241 |
| Manufacturer | ZIMMER ORTHOPAEDICS SURGICAL PR |
| Manufacturer Address | 2021 OLD MOUNTAIN ROAD STATESVILLE NC 28677 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-05 |