FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1547287
·
Received November 20, 2009
Report
- Report Number
- 1030489-2009-01098
- Event Type
- Malfunction
- Date Received
- November 20, 2009
- Date of Event
- October 26, 2009
- Report Date
- October 26, 2009
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 # 75447550, 510K # K042025 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE AND DEVICE HISTORY RECORD IS UNDER REQUESTING. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS FOUND THAT THE PEDICLE SCREWS WERE LOOSENED AT BOTH SIDE L5 AT A REMOVAL PROCEDURE FOR A BACKED OUT INTERBODY DEVICE. THE SCREWS WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | BONE SCREW | KWP | WARSAW ORTHOPEDIC INC. | NA | H08J7938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | CAGE CATALOG# X050294, LOT# W05M4304 |