FDA Adverse Event
Malfunction
Summary report: N
3MM DRIVER LARGE AXIAL DRIVER
MDR report key: 3770721
·
Received February 18, 2014
Report
- Report Number
- 2032593-2014-00006
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Date of Event
- January 24, 2014
- Report Date
- January 25, 2014
- Manufacturer
- SEA SPINE, INC.
- Product Code
- MAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
"TIP OF DRIVER TWISTED AND STRIPPED DURING SCREW REMOVAL." ON (B)(6) 2014 ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHO REPORTED DURING THE REMOVAL SURGERY OF A SCREW AT L4 LEVEL, 2 DRIVER TIPS TWISTED AND STRIPPED. THERE WAS NO INJURY TO THE PT BUT A DIFFERENT INSERTION DRIVER HAD TO BE USED TO COMPLETE THE SURGERY. SURGERY WAS DELAYED BY 20 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101319 | 3MM DRIVER LARGE AXIAL DRIVER | UCR | MAX | SEA SPINE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |