RESPONSE 5.5/6.0 SPINE SYSTEM

Description of Event or Problem

IDIOPATHIC SCOLIOSIS SURGERY ON (B)(6) YEAR OLD FEMALE WITH 50 DEGREE CURVE TREATED WITH RESPONSE 5.5/6.0 SYSTEM PEDICLE SPINAL SYSTEM. IMMEDIATE POST OP X-RAYS SHOW DISTAL MOST SCREW ON RIGHT SIDE PLACED VERY NEAR END OF ROD, WITH CONCERNS EXPRESSED AT TIME OF SURGERY BY COMPANY REPRESENTATIVE THAT THIS COULD BECOME A PROBLEM. SUBSEQUENT FOLLOW UP X-RAYS AT 10 DAYS POST OP SHOWED THE LOWER RIGHT SIDE OF THE CONSTRUCT HAD DISSOCIATED. SURGEON ELECTED TO WAIT AND SEE IF FUSION DEVELOPED. ABOUT 13 MONTHS POST OP, PATIENT NOTED A POPPING SOUND. SUBSEQUENT XRAY SHOWED THE LOWER LEFT SIDE OF THE CONSTRUCT HAD DISSOCIATED. THIS PARTICULAR DISSOCIATION (DISTAL LEFT) LOOKED LIKE THE HEAD OF THE SCREW SHANK HAD COME OUT OF THE TULIP HEAD. DEVICES INVOLVED WERE 6.5 MM PEDICLE SCREWS AND 6.0MM COCR DIAMETER ROD. REVISION SURGERY PERFORMED ON (B)(6) 2017: ROD WAS EXTENDED ON RIGHT SIDE VIA USE OF STRYKER XIA 2 SYSTEM ROD APPROXIMATELY 75 MM IN LENGTH PLACED IN PARALLEL WITH EXISTING ROD TO EXTEND OVERALL ROD LENGTH. BOTH DISTAL MOST SCREWS REPLACED ALONG WITH WEDDING BAND CONNECTOR AND (5) SET SCREWS TOTAL. PATIENT OUTCOME SUCCESSFUL BUT SURGEON NOTED A SLIGHT COMPRESSION ON RIGHT SIDE.

Additional Manufacturer Narrative

RECALL NUMBER: 3006460162-04-11-2017-001-C. A POST OPERATIVE X-RAY WAS PROVIDED AND THE COMPLAINT WAS CONFIRMED. A DEVICE HISTORY RECORDS REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE SURGEON NOT ADEQUATELY FOLLOWING THE STEPS OUTLINED IN THE SURGICAL TECHNIQUE FOR "FINAL TIGHTENING" OF THE SET SCREW AND THE CONFIRMATION THAT THE ROD IS FULLY SEATED INTO THE BOTTOM OF THE PEDICLE SCREW PRIOR TO TINAL TIGHTENING. UPDATED SURGICAL TECHINIQUE, SALES REP NOTIFICATIONS AND TRAINING HAS BEEN UPDATED AND/OR DISTRIBUTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.