MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-05-21 for WILSON FRAME 5319G manufactured by Mizuho Orthopedic Systems, Inc..
[15219788]
Pt was prolined on wilson frame for a laminectomy decompression. When the rn started to manually crank the pt into position, the entire plastic bottom cracked across the entire width. (b)(6); the maximum frame's weight is 250 lbs. No harm to pt and the surgery was completed without having to remove pt from frame.
Patient Sequence No: 1, Text Type: D, B5
[15657959]
We will contact customer to see if failed component can be returned for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2010-00008 |
| MDR Report Key | 1714351 |
| Report Source | 00 |
| Date Received | 2010-05-21 |
| Date of Report | 2010-05-20 |
| Date of Event | 2010-03-12 |
| Report Date | 2010-04-23 |
| Date Mfgr Received | 2010-05-01 |
| Device Manufacturer Date | 2004-05-05 |
| Date Added to Maude | 2010-10-01 |
| 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 AVE. |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| 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 | OPERATING ROOM TABLE, ACCESSORY |
| Product Code | JEB |
| Date Received | 2010-05-21 |
| Model Number | 5319G |
| Catalog Number | 5319G |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 0 | 2010-05-21 |