FDA Adverse Event
Other
Summary report: N
WILSON FRAME
MDR report key: 1531405
·
Received November 12, 2009
Report
- Report Number
- 2921578-2009-00013
- Event Type
- Other
- Date Received
- November 12, 2009
- Date of Event
- October 4, 2009
- Report Date
- November 4, 2009
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RETURNED DEVICE SHOWED EVIDENCE OF STAINING FROM A CHEMICAL IN THE AREAS OF THE FAILURE. WE FIND THIS A UNIQUE EVENT AND WILL CONTINUE TO MONITOR.
Description of Event or Problem · 1
WHEN FLIPPING PATIENT FROM SUPINE POSITION TO PRONE POSITION ONTO THE JACKSON SPINAL TABLE WITH THE WILSON FRAME ADDED TO THE TABLE. DURING THE FLIP (ROTATION), THE FRAME BROKE LEAVING THE PATIENT UNEVEN ON THE SURGICAL TABLE. A NEW FRAME WAS INSTALLED AND PATIENT WAS REPOSITIONED ON FRAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WILSON FRAME | ACCESSORIES, OPERATING ROOM TABLE | JEB | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 5321G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | 5943 ADVANCED CONTROL BASE| 5803 ADVANCED CONTROL BASE |