FDA Adverse Event
Summary report: N
CURVTEK
MDR report key: 2010935
·
Received February 23, 2011
Report
- Report Number
- 2010935
- Date Received
- February 23, 2011
- Date of Event
- January 24, 2011
- Report Date
- February 23, 2011
- Manufacturer
- BIOMET, INC.
- Product Code
- GFG
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
NOTIFIED BY BIOMET VENDOR. SALES REPRESENTATIVE IN THE FIELD REPORTS TIP BREAKAGE AND SUBMITS DEVICE PART NUMBER AND LOT NUMBER TO BIOMET COMPANY. BIOMET REPORTS THAT THE SURGERY TEAM DID NOT THINK THE EVENT WAS SIGNIFICANT ENOUGH TO SAVE THE PART OR REPORT THE EVENT. THERE WAS NO INJURY TO THE PATIENT, AS THE SURGEON REMOVED THE BROKEN TIP AND PROCEEDED WITH THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURVTEK | ORTHOPEDIC TUNNELING DEVICE | GFG | BIOMET, INC. | 906750 | 588880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |