MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-19 for * 1066-005 manufactured by Zimmer Orthopaedic Surgical Pr.
[397627]
Trapeze frame broke at offset double clamp bar (35" or 89cm) while in use on pt post-surgery. Didn't hit pt, no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2005-00003 |
| MDR Report Key | 595500 |
| Report Source | 05 |
| Date Received | 2005-04-19 |
| Date of Report | 2005-03-21 |
| Date of Event | 2004-12-29 |
| Date Facility Aware | 2005-02-15 |
| Report Date | 2005-03-21 |
| Date Mfgr Received | 2005-03-15 |
| Date Added to Maude | 2005-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JOYCE ELKINS |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| 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 |
| Brand Name | * |
| Generic Name | TRAPEZE FRAME OFFSET DOUBLE CLAMP BAR |
| Product Code | ILZ |
| Date Received | 2005-04-19 |
| Model Number | * |
| Catalog Number | 1066-005 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 585326 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PR |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US |
| Baseline Brand Name | * |
| Baseline Generic Name | TRAPEZE FRAME OFFSET DOUBLE CLAMP BAR |
| Baseline Model No | * |
| Baseline Catalog No | 1066-005 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-19 |