FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 4122640
·
Received September 26, 2014
Report
- Report Number
- 1030489-2014-03744
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 28, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- NKB
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR THORACOLUMBAR DECOMPRESSION AT T7-ILIUM. IT WAS REPORTED THAT DURING TIGHTENING OF THE SET SCREW INTO THE BONE SCREW THE THREADS OF THE SETSCREW SHEARED OFF AND FELL INTO THE BONE SCREW. THE WOUND WAS IRRIGATED WITH SALINE TO REMOVE THE METAL DEBRIS. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601413 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | NKB | MEDTRONIC SOFAMOR DANEK | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BONE SCREW |