FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3902971
·
Received June 30, 2014
Report
- Report Number
- 1030489-2014-02962
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- April 23, 2014
- Report Date
- June 2, 2014
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- NKB
- PMA / PMN Number
- K113174
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SCREWS IMPLANTED AT S1 BILATERALLY BROKE ALONG THE SHAFT BELOW THE SCREW HEAD. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379192 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | H13J0246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | RODS, SET SCREWS |