FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 4151752
·
Received October 8, 2014
Report
- Report Number
- 1030489-2014-03916
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- February 1, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (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 AT T12-L4 TO TREAT A L2 FRACTURE. SOMETIME POST-OP IT WAS REPORTED THAT THE BONE SCREWS HAD LOOSENED AND THE PATIENT HAD NOT ACHIEVED BONE UNION. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH ALL OF THE HARDWARE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633451 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR | Hospitalization| R | SCREWS, RODS |