MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-20 for CASPAR CERVICAL SCREW manufactured by Unknown.
[12381]
Removed and replaced cervical plate and 6 screws because two screws had broken. Original insertion at another facility, no mfr info available. Pt states implant date mid 1991. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 23066 |
| MDR Report Key | 23066 |
| Date Received | 1995-05-20 |
| Date of Report | 1995-05-17 |
| Date of Event | 1995-04-21 |
| Date Facility Aware | 1995-04-26 |
| Report Date | 1995-05-17 |
| Date Reported to FDA | 1995-05-17 |
| Date Added to Maude | 1995-06-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASPAR CERVICAL SCREW |
| Generic Name | SCREWS |
| Product Code | HHO |
| Date Received | 1995-05-20 |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 23305 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-05-20 |