FDA Adverse Event
Injury
Summary report: N
TOGGLELOC ELBOW IMPLANT SYSTEM
MDR report key: 1903931
·
Received November 20, 2010
Report
- Report Number
- 1825034-2010-00603
- Event Type
- Injury
- Date Received
- November 20, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 21, 2010
- Manufacturer
- BIOMET SPORTS MEDICINE, INC.
- Product Code
- MBI
- PMA / PMN Number
- K083070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT ELBOW PROCEDURE ON (B)(6) 2010. AS THE SURGEON WENT TO TIGHTEN THE TOGGLELOC, IT BECAME STUCK, AND WOULD NOT ADVANCE. SURGEON REMOVED THE TOGGLELOC AND USED FIBER WIRE TO COMPLETE THE PROCEDURE, BUT ONLY AFTER A DELAY OF MORE THAN HALF AN HOUR HAD OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOGGLELOC ELBOW IMPLANT SYSTEM | FASTENER, FIXATION | MBI | BIOMET SPORTS MEDICINE, INC. | N/A | 228020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |