MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-07-29 for 5890 FIXED JACKSON TABLE BASE manufactured by Orthopedic Systems, Inc..
[326043]
Pt placed in a supine position on the fracture table, and their arms were brought across pt and held in place by a draw sheet and two surgical clips. The pt's left foot was placed in a leg holder, and their right foot was having traction applied manually. A physician was in attendance on the pt's right side, a pelvic holder was in place between pt's legs for positioning when the bottom piece of the fracture table was removed. With elevation of the bed, the pt was pulled to the right side, slid and subsequently fell against the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2003-00002 |
| MDR Report Key | 476010 |
| Report Source | 06 |
| Date Received | 2003-07-29 |
| Date of Report | 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 | ORTHPEDIC 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 | 464836 |
| 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 | 2003-07-29 |