MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-04-05 for 5319G WILSON FRAME manufactured by Mizuho Orthopedic Systems, Inc.
[1519449]
During use of the wilson frame, the frame separated and the patient dropped onto table suffering a laceration to the head.
Patient Sequence No: 1, Text Type: D, B5
[8542654]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2010-00004 |
| MDR Report Key | 1656259 |
| Report Source | 06,07 |
| Date Received | 2010-04-05 |
| Date of Report | 2010-03-01 |
| Date of Event | 2010-03-01 |
| Date Mfgr Received | 2010-03-01 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 2010-10-05 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | S.A.A. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5319G WILSON FRAME |
| Generic Name | OPERATING ROOM TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2010-04-05 |
| Returned To Mfg | 2010-03-25 |
| Model Number | 5319G |
| Catalog Number | 5319G |
| ID Number | DOM 5/1999 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-05 |