MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-25 for EXACTECH CE * manufactured by Exactech, Inc..
[942410]
While orthopedic surgeon was tapping in the ligament balancing system, a piece broke off. No retained pieces in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1161259 |
| MDR Report Key | 1161259 |
| Date Received | 2008-08-25 |
| Date of Report | 2008-08-25 |
| Date of Event | 2008-08-14 |
| Report Date | 2008-08-25 |
| Date Reported to FDA | 2008-08-25 |
| Date Added to Maude | 2008-09-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | EXACTECH CE |
| Generic Name | LIGAMENT BALANCING SYSTEM, TOTAL KNEE |
| Product Code | LXI |
| Date Received | 2008-08-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1181827 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 NORTH WEST 66TH COURT GAINESVILLE FL 32653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-25 |