FDA Adverse Event
Other
Summary report: N
5319G WILSON FRAME
MDR report key: 1656259
·
Received April 5, 2010
Report
- Report Number
- 2921578-2010-00004
- Event Type
- Other
- Date Received
- April 5, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 1, 2010
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC
- Product Code
- JEB
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE EVALUATED THE RETURNED DEVICE AND FOUND IT TO BE WITHIN SPECIFICATION. THE DEVICE WAS FULLY FUNCTIONAL WITH A FEW REPAIR ISSUES THAT IS CONSIDERED NOT RELATED TO THE EVENT (MISSING RUBBER WEAR PAD ON BASE AND THE PADS THAT SUPPORT THE PATIENT WERE TORN). WE CONSIDERED THIS TO BE USER ERROR AND WILL CONTINUE TO MONITOR. (B)(4) 2010.
Description of Event or Problem · 1
DURING USE OF THE WILSON FRAME, THE FRAME SEPARATED AND THE PATIENT DROPPED ONTO TABLE SUFFERING A LACERATION TO THE HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5319G WILSON FRAME | OPERATING ROOM TABLE ACCESSORY | JEB | MIZUHO ORTHOPEDIC SYSTEMS, INC | 5319G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |