FDA Adverse Event
Injury
Summary report: N
POLYAXIAL REDUCTION SCREW 7.5 X 50MM
MDR report key: 4317496
·
Received December 2, 2014
Report
- Report Number
- 2032593-2014-00058
- Event Type
- Injury
- Date Received
- December 2, 2014
- Date of Event
- December 1, 2014
- Report Date
- November 5, 2014
- Manufacturer
- SEASPINE, INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
IT IS REPORTED THAT FOLLOWING A SURGERY PERFORMED ON (B)(6) 2011, THE SCREW HEAD BROKE OFF IN THE PT. A REVISION SURGERY WAS REPORTED TO BE SCHEDULED FOR (B)(6) 2014. ADDITIONAL INFO HAS BEEN REQUESTED. ADD'L INFO WAS RECEIVED: THE ORIGINAL PROCEDURES OCCURRED ON (B)(6) 2014 AND (B)(6) 2014. ON (B)(6) 2014, THE PT UNDERWENT A BROKEN SCREW REMOVAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 776300 | POLYAXIAL REDUCTION SCREW 7.5 X 50MM | CORAL MIS | KWP | SEASPINE, INC. | W10275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |