RESPONSE 5.5/6.0 SPINE SYSTEM

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTIONS: PATIENT AGE, UDI, EXPLANT DATE. ADDITIONAL INFORMATION: CUSTOMER DID NOT RETURN THE EXPLANTED DEVICES TO ORTHOPEDIATRICS, CORP. CORRECTION/REMOVAL NUMBER: 3006460162-04-11-2017-001-C. 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 TECHNIQUE, 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.

Description of Event or Problem

SCHEUERMANN'S KYPHOSIS CASE DONE (B)(6) 2016. USED ALL POLY SCREWS AND 6.0 COBALT CHROME RODS. PATIENT CAME BACK FOR 1 YEAR FOLLOW UP, AND BOTTOM 3 SCREWS ON BOTH SIDES BECAME DISENGAGED. AT TIME OF REVISION SURGERY, SALES REP NOTED THAT SURGEON STATED THAT HE HAD USED THE WRONG INSTRUMENT (JIMMY DEVICE) TO ACTUALLY REDUCE ROD INTO PEDICLE SCREWS, SO THEREFORE THEY WERE NOT TIGHTENED AS HE HAD THOUGHT.