MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-31 for HANA ORTHOPEDIC SURGERY TABLE manufactured by Mizuno Osi.
[15128127]
Boot and lower extremity fell from positioner approx 1 foot. Fastener holding extremity loosened and extremity fell. The surgery being performed: total hip arthroplasty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039955 |
| MDR Report Key | 4387174 |
| Date Received | 2014-12-31 |
| Date of Report | 2014-12-29 |
| Date of Event | 2014-07-07 |
| Date Added to Maude | 2015-01-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANA ORTHOPEDIC SURGERY TABLE |
| Generic Name | LOWER EXTREMITY FASTENER |
| Product Code | JEB |
| Date Received | 2014-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUNO OSI |
| Manufacturer Address | UNION CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-31 |