FDA Adverse Event
Other
Summary report: N
MALIBU TORQUE LIMITING DRIVER
MDR report key: 1105217
·
Received August 7, 2008
Report
- Report Number
- 2032593-2008-00001
- Event Type
- Other
- Date Received
- August 7, 2008
- Date of Event
- July 10, 2008
- Report Date
- July 10, 2008
- Manufacturer
- SEASPINE, INC.
- Product Code
- LXH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MALIBU TORQUE LIMITING DRIVER IS DESIGNED FOR TIGHTENING DOWN REDUCTION SCREWS DURING SPINAL SURGERY IN THE FINAL CONSTRUCT. THE DEVICE WAS USED AS A REMOVAL TOOL, CAUSING THE HANDLE TO UNSCREW FROM THE SHAFT. THERE HAS NEVER BEEN ANY REPORTS OF THIS NATURE WITH OUR TORQUE LIMITING DRIVERS. THE RETURNED INSTRUMENT IS BEING EVALUATED AT THIS TIME.
Description of Event or Problem · 1
THE DOCTOR WAS TAKING A CAP OFF OF A SCREW WHEN THE TORQUE DRIVER UNSCREWED FROM THE SHAFT RESULTING IN DEBRIS FROM THE HANDLE FALLING INTO THE PATIENT. THE DOCTOR FEELS THAT HE WAS ABLE TO REMOVE MOST OF THE DEBRIS BUT COULD NOT BE CERTAIN. NO FURTHER COURSE OF ACTION WAS TAKEN AS THE INSTRUMENT HAD BEEN WELL CLEANED AND STERILIZED PRIOR TO THE SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALIBU TORQUE LIMITING DRIVER | 888.4540 ORTHOPEDIC MAN SURG. INSTRUMENT | LXH | SEASPINE, INC. | NA | B584665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | IMPLANTS| AND SCREWS FOR SPINAL SURGERY |