FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2860330
·
Received December 6, 2012
Report
- Report Number
- 1030489-2012-02598
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- NKB
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 LUMBAR FUSION PROCEDURE. IT WAS REPORTED THAT THE SCREWS HAD LOOSENED IN THE BONE AND COULD ACTUALLY BE WIGGLED IN THE PEDICLE. A REVISION SURGERY WAS PERFORMED. THE SCREWS WERE ALL 6.5 DIAMETER SCREWS BUT THE "HALO" AROUND THE SCREWS ON THE SCAN SHOWED THE HOLE WAS NOW ABOUT 10-10.5MM. 9.5 DIAMETER SCREWS WERE USED TO REPLACE THE SCREWS. THE CONSTRUCT WAS EXTENDED TO T10-PELVIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |