MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-03 for SURGICAL INSTRUMENT ELEVATOR RH750 manufactured by V. Mueller Div. Baxter Healthcare Corp..
[25847]
During orthopedic/surgical repair of fractured tibia, the tip of the elevator broke off in wound. It was then located under fluoroscopy and the tip was retrieved by the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009426 |
| MDR Report Key | 33894 |
| Date Received | 1996-07-03 |
| Date of Report | 1996-06-26 |
| Date of Event | 1996-05-11 |
| Date Added to Maude | 1996-07-09 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | SURGICAL INSTRUMENT ELEVATOR |
| Generic Name | SURGICAL INSTRUMENT ELEVATOR |
| Product Code | GEG |
| Date Received | 1996-07-03 |
| Model Number | RH750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35234 |
| Manufacturer | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 1662 COLLINS HILL RD LAWRENCEVILLE GA 30243 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-03 |