MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-07 for ZIMMER 2822-02 manufactured by Zimmer, Inc..
[893948]
Surgeon was using a small cobb elevator during the procedure, and the tip broke off in the disc space. The c-arm was brought in to see where the end of the elevator was. Surgeon was able to remove the tip of the elevator about an hour later, once the space was open enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1113043 |
| MDR Report Key | 1113043 |
| Date Received | 2008-07-07 |
| Date of Report | 2008-05-06 |
| Date of Event | 2008-05-01 |
| Report Date | 2008-05-06 |
| Date Reported to FDA | 2008-07-07 |
| Date Added to Maude | 2008-08-15 |
| 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 | ZIMMER |
| Generic Name | INSTRUMENT, ORTHOPEDIC |
| Product Code | GEG |
| Date Received | 2008-07-07 |
| Returned To Mfg | 2008-05-06 |
| Model Number | 2822-02 |
| Catalog Number | 2822-02 |
| Lot Number | N/A |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1097077 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 345 EAST MAIN STREET WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-07 |