FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2873435
·
Received December 14, 2012
Report
- Report Number
- 1030489-2012-02810
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 15, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- MNI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 SURGERY AT T9-L5 TO TREAT SCOLIOSIS. IT WAS REPORTED THAT THE L5 SCREW LOOSENED AS WELL AS THE CAGE (COMPETITOR) BACKING OUT. THE PATIENT COMPLAINED OF PAIN. THE PATIENT UNDERWENT A REVISION 7 MONTHS POST-OP. THE IMPLANTS WERE REMOVED AND REPLACED AS WELL AS EXTENDED TO THE ILIAC. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION | MNI | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00028 YR | Required Intervention |