MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-17 for TRAPEZE, HEAVY DUTY 00-0640-067-00 manufactured by Zimmer Orthopaedic Surgical Products.
[1043752]
The locking nut that secures patient helper frame to trapeze backed up and trapeze fell from frame onto patient.
Patient Sequence No: 1, Text Type: D, B5
[8148822]
The trapeze was the only piece returned for evaluation. The frame was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2008-00016 |
| MDR Report Key | 1321640 |
| Report Source | 05 |
| Date Received | 2008-12-17 |
| Date of Report | 2008-11-17 |
| Date of Event | 2008-08-18 |
| Date Mfgr Received | 2008-11-17 |
| Date Added to Maude | 2010-04-20 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN WATKINS |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Street | 2021 OLD MOUNTAIN RD |
| Manufacturer City | STATESVILLE NC 28677 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAPEZE, HEAVY DUTY |
| Generic Name | TRAPEZE |
| Product Code | ILZ |
| Date Received | 2008-12-17 |
| Returned To Mfg | 2008-11-17 |
| Catalog Number | 00-0640-067-00 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | STATESVILLE NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-17 |