FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2895262
·
Received January 3, 2013
Report
- Report Number
- 1030489-2013-00013
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 6, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- PMA / PMN Number
- K052187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
(B)(4): MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SETSCREW SLIPPED DURING INSERTION. THE SCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2177 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | H10K1241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | BONE SCREW |