FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3964719
·
Received July 29, 2014
Report
- Report Number
- 1030489-2014-03335
- Event Type
- Malfunction
- Date Received
- July 29, 2014
- Date of Event
- June 30, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- PMA / PMN Number
- K981676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): MACROSCOPIC 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. FUNCTIONAL EVALUATION WITH A SAMPLE MAS FOUND THE IMPLANT UNABLE TO BE FULLY ENGAGED INTO THE MAS HEAD. 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 TO TREAT A T2 CHEST FRACTURE. IT WAS REPORTED THAT THE SET SCREWS SLIPPED DURING INSERTION INTO THE BONE SCREWS. THE SCREWS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442096 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | H5088181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00021 YR | BONE SCREW |