MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-04 for OSI MODULAR TABLE 5803 manufactured by Orthopedic Systems, Inc..
[16106600]
Rectangular object discovered upon x-ray with c-arm during surgery with patient positioned prone on jackson table. Object discovered to be inside hip pad attachment to the table. No patient injury occurred and surgery was completed. Company representative notified via phone in 2008. Osi rep robyn mcdaniel said she would get back to us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008861 |
| MDR Report Key | 1220705 |
| Date Received | 2008-11-04 |
| Date of Report | 2008-10-24 |
| Date of Event | 2008-10-09 |
| Date Added to Maude | 2008-11-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | OSI MODULAR TABLE |
| Generic Name | JACKSON TABLE |
| Product Code | JFB |
| Date Received | 2008-11-04 |
| Model Number | 5803 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1273983 |
| Manufacturer | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN UNION CITY CA 94587 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-04 |