FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1870949
·
Received October 7, 2010
Report
- Report Number
- 1030489-2010-01308
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- KWQ
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A MINIMALLY INVASIVE OPERATION L5/S1 WITH AN INTERBODY DEVICE. APPROXIMATELY 1.5 YEARS POST-OP, IT WAS DISCOVERED THAT 2 SCREWS WERE BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE CONSTRUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | BONE SCREW | KWQ | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |