MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-01 for MAYFIELD RADIOLUCENT BASE UNIT 1138 manufactured by Ohio Medical Instrument Co, Inc..
[22070763]
Pt having cervical fusion cy-5, cy-6. Physician using radiolucent headrest to provide rigid skeletal fixation. Pt's head came loose from the frame and dropped to bed. Pin in torque screw locking knob broke. "teeth" sheared off on one side. No adverse effect to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007812 |
| MDR Report Key | 28393 |
| Date Received | 1995-12-01 |
| Date of Report | 1995-11-30 |
| Date of Event | 1995-11-21 |
| Date Added to Maude | 1995-12-05 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD RADIOLUCENT BASE UNIT |
| Generic Name | HEADREST |
| Product Code | HBM |
| Date Received | 1995-12-01 |
| Model Number | 1138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29328 |
| Manufacturer | OHIO MEDICAL INSTRUMENT CO, INC. |
| Manufacturer Address | 3924 VIRGINIA AVE CINNCINATI OH 45227 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-01 |