MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-16 for ZIMMER 1066-005 ZIM CODE035-0 manufactured by Zimmer.
[21612034]
Trapeze frame broke at offset double clamp bar (35" or 89 cm) while in use on patient post-surgery. Didn't hit patient, no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034665 |
| MDR Report Key | 575101 |
| Date Received | 2005-02-16 |
| Date of Report | 2005-02-15 |
| Date of Event | 2004-12-29 |
| Date Added to Maude | 2005-02-24 |
| 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 | ZIMMER |
| Generic Name | TRAPEZE FRAME OFFSET DOUBLE CLAMP BAR |
| Product Code | ILZ |
| Date Received | 2005-02-16 |
| Model Number | 1066-005 |
| Catalog Number | ZIM CODE035-0 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 564949 |
| Manufacturer | ZIMMER |
| Manufacturer Address | PO BOX 951244 DALLAS TX 753951244 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-16 |