Description of Event or Problem · 1
ON (B)(4) 2017, X-SPINE SYSTEMS, INC. RECEIVED EMAIL COMMUNICATIONS REPORTING BROKEN PEDICLE SCREWS. THE EMAIL CONTAINED SIX X-RAYS. THERE WERE NO ADDITIONAL DETAILS IN THE EMAIL COMMUNICATION. X-SPINE MADE THREE ATTEMPTS TO OBTAIN ADDITIONAL COMPLAINT DETAILS. ADDITIONAL DETAILS WERE RECEIVED BY THE COMPLAINANT ON (B)(6) 2018. THE COMPLAINANT STATED THAT "THE DOCTOR SENT THE PATIENT FOR A CONTROL X-RAY AND HE FOUND THAT THE SCREW WAS BROKEN, THE PATIENT NEVER HAD AN INCIDENT THAT MIGHT CAUSE THE BREAKAGE OF THE SCREW." THESE DETAILS CORRESPONDED WITH ONE OF THE X-RAYS. THE REMAINING X-RAYS DEPICT MULTIPLE CASES AND POSSIBLY MULTIPLE PATIENTS, HOWEVER, THE COMPLAINANT ONLY INDICATED THAT IT WAS ONE CASE/ONE PATIENT. X-SPINE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MULTIPLE CASES/PATIENTS. A COMPREHENSIVE REVIEW OF ALL SUPPLIED DATA WAS COMPLETED ON (B)(6) 2018. THE INVESTIGATION INCLUDED A REVIEW OF THE DHF FOR THE SINGLE LOT NUMBER PROVIDED. THE REVIEW WAS UNREMARKABLE AND THERE WERE NO INDICATIONS THAT THE PART WOULD NOT PERFORM AS INTENDED. THE ASSESSMENT OF THE CORRESPONDING X-RAY (#1) SHOWS A BROKEN PEDICLE SCREW SHANK ON THE CAUDAL END OF A 1 LEVEL CONSTRUCT. THERE IS NO INTERBODY DEVICE FOR ANTERIOR COLUMN SUPPORT. IT IS HARD TO TELL IF THERE IS A SOLID POSTERIOR LATERAL FUSION, ALTHOUGH IT MAY HAVE BEEN ATTEMPTED. THE ASSESSMENT OF X-RAY #2 SHOWS A BROKEN PEDICLE SCREW SECOND LEVEL FROM THE CRANIAL END OF THE CONSTRUCT. IT WAS OBSERVED THAT THE CURVATURE OF THE ROD AS MANIPULATED BY THE PHYSICIAN DID NOT MATCH THE CURVATURE OF THE SPINE AT THE IMPLANT SITE. THIS MAY HAVE STRESSED THE PEDICLE SCREW CAUSING BREAKAGE. THE ASSESSMENT OF X-RAY #3 SHOWS A BROKEN PEDICLE SCREW ON THE CAUDAL END OF THE CONSTRUCT. THERE WERE NO ABNORMALITIES IDENTIFIED IN THE ASSESSMENT OF THE X-RAY. THE ASSESSMENT OF X-RAYS #4-6 SHOWS A BROKEN PEDICLE SCREW AT THE CRANIAL END OF THE CONSTRUCT. THE CRANIAL LEVEL DOES NOT HAVE AN INTERBODY DEVICE FOR ANTERIOR COLUMN SUPPORT. THE PROCEDURE DOES NOT APPEAR TO HAVE INCLUDED ANY POSTERIOR FUSION. THE SURGICAL TECHNIQUE GUIDES FOR EACH PEDICLE SCREW SYSTEM CAUTIONS THAT "FAILURE TO INCORPORATE APPROPRIATE ANTERIOR SUPPORT FOR A POSTERIOR PEDICLE SCREW CONSTRUCT MAY RESULT IN ABNORMAL LOADING, FAILURE OR LOOSENING OF THE CONSTRUCT." IF THERE IS NOT A SOLID FUSION OR IF THE ROD CONTOUR IS NOT APPROPRIATE, PEDICLE SCREWS MAY HAVE A TENDENCY TO FAIL. WHEN THIS HAPPENS, THE BREAKAGE TYPICALLY OCCURS AT THE END OF A CONSTRUCT AND USUALLY OCCURS MID SHAFT ON THE SCREW. PATIENT INFORMATION WAS NOT AVAILABLE, HOWEVER, IF THE PATIENT IS INVOLVED IN AN OCCUPATION OR ACTIVITY WHICH APPLIES INORDINATE STRESS UPON THE IMPLANT (E.G SUBSTANTIAL WALKING, RUNNING, LIFTING, OR MUSCLE STRAIN) RESULTANT FORCES CAN CAUSE FAILURE OF THE DEVICE. INTERNAL FIXATION DEVICES CANNOT WITHSTAND ACTIVITY AND LOAD LEVELS EQUAL TO THOSE PLACED ON NORMAL HEALTHY BONE UNTIL MATURATION OF THE FUSION MASS IS CONFIRMED. REVISION PROCEDURES WERE NOT PLANNED.