MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-12 for WILSON FRAME 5321G manufactured by Mizuho Orthopedic Systems, Inc..
[1246724]
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.
Patient Sequence No: 1, Text Type: D, B5
[8504716]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2009-00013 |
| MDR Report Key | 1531405 |
| Report Source | 05 |
| Date Received | 2009-11-12 |
| Date of Report | 2009-11-04 |
| Date of Event | 2009-10-04 |
| Date Mfgr Received | 2009-10-13 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2011-03-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE. |
| 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 | WILSON FRAME |
| Generic Name | ACCESSORIES, OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2009-11-12 |
| Returned To Mfg | 2009-09-11 |
| Model Number | 5321G |
| Catalog Number | 5321G |
| Device Availability | R |
| 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 AVE. UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5943 | 1. Other | 2009-11-12 |