FDA Adverse Event
Malfunction
Summary report: N
TILOCK PEDICLE PEDUICLE SCREW SYSTEM
MDR report key: 3042567
·
Received April 4, 2013
Report
- Report Number
- 3008455034-2013-00001
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Date of Event
- March 13, 2013
- Report Date
- April 3, 2013
- Manufacturer
- GENESYS SPINE
- Product Code
- NKB
- PMA / PMN Number
- K100757
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SALES REPRESENTATIVE INDICATED IT IS COMMON FOR BONE CHIPS TO ACCUMULATE IN THE TAP AND THAT STANDARD PRACTICE DICTATES THE SURGICAL TECHNICIAN SHOULD CLEAN THE TAP AFTER EACH USE.
Description of Event or Problem · 1
WHILE PLACING A PEDICLE TAP OVER A K-WIRE, SOME RESISTANCE / BLOCKAGE WAS FELT. THIS OCCURRED TWO TIMES DURING THE PROCEDURE USING DIFFERENT K-WIRES AND TAPS. THIS IS MDR REPORT 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138692 | TILOCK PEDICLE PEDUICLE SCREW SYSTEM | BONE TAP | NKB | GENESYS SPINE | GLC155 | 104201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | MIS PEDICLE SCREWS| LORDOTIC TLIF| K-WIRE| RODS |