FDA Adverse Event
Other
Summary report: N
CORAL PEDICLE SCREW SYSTEM
MDR report key: 1366118
·
Received January 26, 2009
Report
- Report Number
- 1530901-2009-00001
- Event Type
- Other
- Date Received
- January 26, 2009
- Date of Event
- November 25, 2008
- Report Date
- January 26, 2009
- Manufacturer
- THEKEN SPINE LLC
- Product Code
- NKB
- PMA / PMN Number
- K070962
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT# W7483. THE PATIENT WAS A MUSCULAR MALE WITH VERY DENSE BONE. THE SURGEON TRIED UNSUCCESSFULLY TO PLACE BOTH SCREWS (SAME LOCATION). FOR THE THIRD ATTEMPT, HE USED THE TAP SUPPLIED IN THE CORAL INSTRUMENT SET AND INSERTED THE SCREW WITHOUT INCIDENT.
Description of Event or Problem · 1
POLYAXIAL SCREWS SEPARATED WHILE BEING INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORAL PEDICLE SCREW SYSTEM | POLYAXIAL PEDICLE SCREW | NKB | THEKEN SPINE LLC | 18-12-6540 | W8665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |