BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEX PEDICLE SCREW SYSTEM

    MDR report key: 10466059 · Received August 28, 2020

    Report

    Report Number
    3005031160-2020-00018
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 28, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    MNI
    UDI-DI
    M697X02200961
    PMA / PMN Number
    K152132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FROM A FOREIGN DISTRIBUTOR REGARDING A PRODUCT COMPLAINT FROM A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. THE COMPLAINANT REPORTED THAT THE THREADING ON A PEDICLE SCREW AND PEDICLE SCREW CAP WERE STRIPPED WHEN FINAL TIGHTENING THE CAP AFTER ROD INTRODUCTION WAS PERFORMED. THE COMPLAINT PEDICLE SCREW AND CAP WERE REMOVED AND REPLACED WITH ALTERNATE DEVICES WITH NO FURTHER ISSUES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT. A PHOTO PROVIDED SHOWED A PEDICLE SCREW AND ASSOCIATED SYSTEM CAP FROM THE COMPANY, BUT DID NOT IDENTIFY ANY DAMAGE TO THE THREADS. ADDITIONAL PHOTOS SHOWING THE THREADING DAMAGE AND DEVICE LASER MARKINGS WERE REQUESTED, BUT WERE UNAVAILABLE FOR THE COMPLAINT INVESTIGATION. THE SYSTEM SURGICAL TECHNIQUE GUIDE PROVIDES GUIDANCE ON THE INTRODUCTION OF SYSTEM CAPS, ROD REDUCTION, AND FINAL LOCKING OF SYSTEM CAPS. CAUTIONARY STATEMENTS ARE INCLUDED IN THE SURGICAL TECHNIQUE GUIDE WHICH STATE, "AVOID PLACEMENT OF A BENT-ROD APEX INTO THE LOCKING ZONE OF A SCREW. THIS MAY RESULT IN ABNORMAL LOCKING TORQUE, SCREW DAMAGE, OR WEAKENING OF FIXATION." THE CAUTIONARY STATEMENT INCLUDED IN THE ROD REDUCTION STEP OF THE SURGICAL TECHNIQUE GUIDE STATES, "APPLICATION OF EXCESSIVE FORCE ONTO THE PISTOL GRIP REDUCER (OR PERSUADER INSTRUMENT) CAN RESULT IN SCREW DAMAGE, INSTRUMENT DAMAGE, SCREW PULLOUT, PEDICLE FRACTURE, AND/OR NEUROLOGICAL INJURY. DO NOT EXCEED PHYSIOLOGICAL FORCES IN REDUCING THE ROD. IF UNABLE TO REDUCE, CONSIDER ADDITIONAL ROD CONTOURING, SCREW RELOCATION, OR IN SITU FUSION." IT MAY BE POSSIBLE THAT IF ROD REDUCTION WAS NOT ADEQUATELY PERFORMED, IT COULD PREVENT THE CAP FROM THREADING ONTO THE CUP OF THE PEDICLE SCREW AS INTENDED. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THE COMPLAINT INVESTIGATION SUGGESTS THE POSSIBILITY THAT THE SYSTEM ROD WAS NOT ADEQUATELY CONTOURED OR NOT APPROPRIATELY REDUCED PRIOR TO FINAL TIGHTENING THE CAP.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FROM A FOREIGN DISTRIBUTOR REGARDING A PRODUCT COMPLAINT FROM A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. THE COMPLAINANT REPORTED THAT THE THREADING ON A PEDICLE SCREW AND PEDICLE SCREW CAP WERE STRIPPED WHEN FINAL TIGHTENING THE CAP AFTER ROD INTRODUCTION WAS PERFORMED. THE COMPLAINT PEDICLE SCREW AND CAP WERE REMOVED AND REPLACED WITH ALTERNATE DEVICES WITH NO FURTHER ISSUES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929978 FORTEX PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI XTANT MEDICAL X022-0096 14615 M697X02200961

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other