FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3012503
·
Received March 20, 2013
Report
- Report Number
- 1030489-2013-00785
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- December 18, 2012
- Report Date
- February 19, 2013
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWP
- PMA / PMN Number
- K011508
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). LOCATION: HOSPITAL. MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST WITNESS MARKS APPROXIMATELY 180 DEGREES APART FROM EACH OTHER. FUNCTIONAL EVALUATION WITH A SAMPLE RMAS FOUND THE IMPLANT ABLE TO BE FULLY ENGAGED INTO THE RMAS HEAD. AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING IT'S INTENDED FUNCTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT DURING TIGHTENING THE SET SCREW WAS DAMAGED. THE SCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115558 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | NA | 0137449W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00037 YR |