MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-05 for MIDMARK 703 * manufactured by Chick Surgical Systems (midmark).
[15604838]
Table adaptor broke during positioning phase of im rodding procedure. Surgeon was able to rig a make shift traction set to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034351 |
| MDR Report Key | 566727 |
| Date Received | 2005-01-02 |
| Date of Report | 2004-12-28 |
| Date of Event | 2004-12-28 |
| Date Added to Maude | 2005-01-24 |
| 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 | MIDMARK |
| Generic Name | FRACTURE TABLE |
| Product Code | INW |
| Date Received | 2005-01-05 |
| Model Number | 703 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 556520 |
| Manufacturer | CHICK SURGICAL SYSTEMS (MIDMARK) |
| Manufacturer Address | 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-02 |