MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-07-29 for 5890, FIXED JACKSON TABLE BASE manufactured by Orthopedic Systems, Inc..
[302117]
Pt was taken to surgery, placed in supine position on the fracture table. At the end of the case after foot board had been replaced, the pt was moving on the fracture table. Staff members were positioned on both sides of the pt. Safety strap was in place over chest. As center post was removed, and staff member turned to put it down, the pt attempted to roll causing their legs to fall off the table. The safety strap caught the pt's upper body as the strap was released by the other staff member and the pt was lowered gently to floor. The physician was notified and examined the pt. The pt was lifted into a hospital bed and x-rays were taken. Exam and x-rays were negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2003-00003 |
| MDR Report Key | 476053 |
| Report Source | 05 |
| Date Received | 2003-07-29 |
| Date of Report | 2003-03-17 |
| Date Mfgr Received | 2003-07-18 |
| Date Added to Maude | 2003-08-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVE |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5890, FIXED JACKSON TABLE BASE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | BWN |
| Date Received | 2003-07-29 |
| Model Number | 5890 |
| Catalog Number | 5890 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 464879 |
| Manufacturer | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE UNION CITY CA 945871234 US |
| Baseline Brand Name | 5890 FIXED JACKSON TABLE BASE |
| Baseline Generic Name | OPERATING ROOM TABLE |
| Baseline Model No | 5890 |
| Baseline Catalog No | 5890 |
| Baseline Device Family | JACKSON TABLE SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5927 | 1. Required No Informationntervention | 2003-07-29 |