FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3970227
·
Received July 31, 2014
Report
- Report Number
- 1030489-2014-03368
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO: MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; ADDITIONALLY, THERE ARE TWO PORTIONS OF THREADS ¿90¿ APART THAT APPEAR TO HAVE MORE PRONOUNCE DAMAGE THAN THE REST, CONSISTENT WITH POSSIBLE THREAD JUMPING.
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBER INTERBODY FUSION AT L4-5. IT WAS REPORTED THAT THE SET SCREW WOULD NOT BREAK OFF IN THE BONE SCREW. THE SCREW WAS REMOVED AND REPLACED WITH A NEW SET SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447225 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | H13T4421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | BONE SCREW |