RESPONSE 5.5/6.0 SPINE SYSTEM
Received Sep 6, 2016
Report 3006460162-2016-00002 · MDR key 5930748
Device
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Congenital Defect/Deformity
- Congenital Defect/Deformity
Narrative
Additional Manufacturer Narrative
SURGEON STATED HE WAS CERTAIN THAT THE DISSOCIATION OCCURRED DUE TO THE ROD NOT BEING FULLY SEATED, AND THE DRIVER NOT BEING ABLE TO OVERCOME THE FORCE OF THE 6.0MM COCR ROD. SURGEON FURTHER STATED THAT WHEN HE PERFORMED THE REVISION SURGERY ON THE PATIENT, HE OBSERVED THAT THE ROD WAS NOT FULLY SEATED. UPON UTILIZING THE REDUCTION TOWER TO FULLY SEAT THE ROD INTO THE PEDICLE SCREW, HE OBSERVED THAT THE ROD DID REDUCE FURTHER. HE THEN FINAL TIGHTENED THE SET SCREW USING THE TORQUE LIMITING DRIVER HANDLE.
Description of Event or Problem
SET SCREW DISASSOCIATED FROM POLYAXIAL SCREW CAUSING ROD TO DISENGAGE FROM POLYAXIAL SCREW. SURGEON DISCOVERED AT 6-WEEK FOLLOW-UP VISIT WITH PATIENT.