MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-16 for CASPAR FF 907 manufactured by Aesculap.
[1919063]
Female patient scheduled for fusion of cervical vertebra c5-c6, c6-c7 (anterior multi level). Drill guide from the anterior cervical set broke intraoperatively. Pieces of the drill guide were recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024467 |
| MDR Report Key | 2024467 |
| Date Received | 2011-03-16 |
| Date of Report | 2011-03-16 |
| Date of Event | 2011-02-23 |
| Report Date | 2011-03-16 |
| Date Reported to FDA | 2011-03-16 |
| Date Added to Maude | 2011-03-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASPAR |
| Generic Name | DRILL GUIDE |
| Product Code | HXY |
| Date Received | 2011-03-16 |
| Model Number | FF 907 |
| Catalog Number | FF 907 |
| Lot Number | AN HOD |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-16 |