FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1241284
·
Received November 20, 2008
Report
- Report Number
- 1030489-2008-00632
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- October 23, 2008
- Report Date
- October 23, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- K042025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES HAVE NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT TREATMENT FOR SPONDYLOLISTHESIS WITH IMPLANT OF TITANIUM POSTERIOR PEDICLE SCREW/ROD FIXATION. SOME TIME POST-OP THE SCREWS AT LEFT AND RIGHT S1 WERE BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE CONSTRUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | SCREW | KWP | MEDTRONIC SOFAMOR DANEK | NA | H07F3631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |