FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1604046
·
Received February 11, 2010
Report
- Report Number
- 1030489-2010-00161
- Event Type
- Malfunction
- Date Received
- February 11, 2010
- Report Date
- January 12, 2010
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- NA
- Product Problem
- 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 # 96509HT, 510K # K981676 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD UNDERGONE MULTIPLE SPINAL PROCEDURE. IT WAS FOUND THAT THE ROD CAME OFF FROM THE CONNECTOR OF A POSTERIOR FIXATION CONSTRUCT AT UNKNOWN TIME POST OP. THE REVISION SURGERY MAY BE PERFORMED; HOWEVER, NO REVISION SURGERY IS REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | AXIAL CONNECTOR | KWP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | SET SCREWS:| IMPLANT:| ROD| BONE SCREWS| IMPLANT:| IMPLANT: |