MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-12 for OFFSET HEAD PUSHER * 7804-18-02 manufactured by Zimmer Orthopaedic Surgical Products.
[353311]
A nonradiolucent piece of plastic broke off the offset head pusher during a hip replacement case. Surgeon attempted to visualize per c-arm at several different angles. Unable to visualize per c-arm. It was surgeon's decision to leave in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 550259 |
| MDR Report Key | 550259 |
| Date Received | 2004-10-12 |
| Date of Report | 2004-09-28 |
| Date of Event | 2004-09-27 |
| Report Date | 2004-09-28 |
| Date Reported to FDA | 2004-10-12 |
| Date Added to Maude | 2004-10-22 |
| 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 | 3 |
| 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 |
| Brand Name | OFFSET HEAD PUSHER |
| Generic Name | OFFSET HEAD PUSHER |
| Product Code | HXO |
| Date Received | 2004-10-12 |
| Model Number | * |
| Catalog Number | 7804-18-02 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 539776 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-12 |