FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1588135
·
Received January 21, 2010
Report
- Report Number
- 1030489-2010-00074
- Event Type
- Malfunction
- Date Received
- January 21, 2010
- Report Date
- December 22, 2009
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 869-021, 510K # K040962 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD UNDERGONE A PROCEDURE AT T10/L2 USING POSTERIOR FIXATION. REPORTEDLY, THE ROD BROKE AT T12 POST OP. FUSION REPORTEDLY COMPLETED. THE REMOVAL SURGERY IS NOT CONFIRMED AT THIS TIME. THE PT REPORTEDLY WAS ASYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | ROD | KWP | WARSAW ORTHOPEDIC INC. | NA | W06A3825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |