CD HORIZON SPINAL SYSTEM
Received Jun 2, 2016
Report 1030489-2016-01616 · MDR key 5694472
Device
Product problems
- Break
- Break
Patient
36 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. HOWEVER, APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, WHOSE REVIEW IS AS FOLLOWS: "L5-S1 CONSTRUCT SCREWS SHOW PROBABLE BILATERAL S1 SCREW BREAKAGE. A SPONDYLOLISTHESIS IS PRESENT. THERE IS NO INTERBODY GRAFT. IT IS UNKNOWN WHAT THE DEGREE OF REDUCTION OF THE SPONDYLOLISTHESIS WAS IMMEDIATELY POST-OP. AN INTERBODY GRAFT MAY HELP WITH DEFORMITY REDUCTION AND FUSION. FUSION STATUS IS UNKNOWN. ROOT CAUSE INDETERMINATE."
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION FROM L5 TO S1 DUE TO SPONDYLOLISTHESIS (GRADE 1) / SPINAL STENOSIS. POST-OP, ON AN UNKNOWN DATE, (AFTER 3 MONTHS), BOTH THE S1 LEVEL SCREWS WERE VISIBLY BROKEN AT THE 4TH OR 5TH THREAD. PATIENT WAS CURRENTLY DOING PHYSIOTHERAPY. THE SCREWS WERE STILL INSIDE THE PATIENT. REPORTEDLY, THE PATIENT WAS OVERALL DOING FINE.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.