RESPONSE 5.5 SPINE SYSTEM
Received Sep 6, 2016
Report 3006460162-2016-00001 · MDR key 5930751
Device
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Congenital Defect/Deformity
- Congenital Defect/Deformity
Narrative
Additional Manufacturer Narrative
SURGEON INFORMED MANUFACTURER THAT THE SET SCREW ON THE LEFT SIDE (MOST DISTAL) WAS PROBABLY CROSS THREADED. THE 6-MONTH FOLLOW UP X-RAYS SHOW THAT THE ROD HAD SLIPPED IN THE AXIALLY DIRECTION AND THE SURGEON CONFIRMED THIS IN THE REVISION SURGERY. ADDITIONALLY, THE NEXT LEVEL UP ON THE LEFT SIDE FROM THE MOST DISTAL SCREW ALSO SHOWED SLIP ALONG THE ROD. THE SURGEON ALSO NOTED SLIPPAGE ON THE SAME TWO MOST DISTAL SCREWS ON THE RIGHT SIDE. THE SURGEON STATED HE WAS UNSURE IF HE USED THE CORRECT TORQUE LIMITER UPON FINAL TIGHTENING. DEVICE NOT RETURNED FOR EVALUATION
Description of Event or Problem
BOTH COCR RODS FOUND TO BE DISASSOCIATED FROM THE DISTAL PEDICLE SCREWS IN CONSTRUCT, VIA X-RAY AT 6-MONTH FOLLOW UP.