FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3973089
·
Received August 1, 2014
Report
- Report Number
- 1030489-2014-03381
- Event Type
- Injury
- Date Received
- August 1, 2014
- Date of Event
- July 4, 2014
- Report Date
- July 4, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
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 TOTAL ENBLOC SPONDYLECTOMY AT T11-L3 WITH A CORPECTOMY AT L1. 9 MONTHS POST-OP, IT WAS FOUND THAT A ROD WAS BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449635 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Required Intervention | SCREW, SET SCREW, VB REPLACEMENT |