FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 4151939
·
Received October 8, 2014
Report
- Report Number
- 1030489-2014-03919
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 6, 2014
- Report Date
- September 23, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SCOLIOSIS PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, THE SURGEON PLACED SCREWS TO CORRECT THE SPINE DEFORMITY. "WHEN THE FINAL POSITION OF THE SCREWS WAS REVIEWED WITH INTRA-OPERATIVE IMAGING, 4 OF THEM WERE NOT IN A CORRECT POSITION. THESE 4 SCREWS WERE REMOVED AND REPOSITIONED CORRECTLY WITHOUT ANY CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632475 | CD HORIZON SPINAL SYSTEM | KWP | MEDTRONIC SOFAMOR DANEK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00014 YR |