FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1181748
·
Received September 18, 2008
Report
- Report Number
- 1030489-2008-00518
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 10, 2007
- Report Date
- August 19, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE TLIF AT L5-S1 USING POSTERIOR ROD AND PEDICLE SCREW FIXATION. IT WAS LATER DETERMINED THAT TWO PEDICLE SCREWS HAD BROKEN WITH RADIOGRAPHIC EVIDENCE OF CONSTRUCT FAILURE. IT WAS REPORTED THAT A REVISION SURGERY WILL NEED TO BE PERFORMED TO REMOVE THE FRACTURED PEDICLE SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | SCREW | KWP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |