FDA Adverse Event
Malfunction
Summary report: N
POLYAXIAL SCREW-SOLID 8.5X75MM
MDR report key: 2516665
·
Received March 30, 2012
Report
- Report Number
- 3008657535-2012-00030
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- March 19, 2012
- Report Date
- March 30, 2012
- Manufacturer
- THEKEN SPINE LLC
- Product Code
- KWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTED STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE TULIP OF THE POLYAXIAL SCREW SPLAYED UPON INSERTION OF THE SET SCREW. IT COULD NOT BE TORQUED. THE DEVICE WAS REMOVED AND WAS REPLACED WITH A LARGER SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYAXIAL SCREW-SOLID 8.5X75MM | CORAL MIS | KWP | THEKEN SPINE LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |