BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE PEDICLE SCREW DRIVER

    MDR report key: 3022915 · Received March 20, 2013

    Report

    Report Number
    3005977257-2013-00006
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 2, 2011
    Report Date
    March 13, 2013
    Manufacturer
    SPINEFRONTIER
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY OF THE PEDFUSE DRIVER WAS REVIEWED AND FOUND TO BE IN COMPLIANCE WITH QUALITY REQUIREMENTS. TWO DRIVERS ARE ALSO SENT WITH EACH SET TO ENSURE THAT A BACKUP IS AVAILABLE TO COMPLETE SURGERY IN THE CASE THAT ONE IS STRIPPED BY THE SURGEON. THE FIELD REP CONFIRMED THAT THE SURGEON HAD TORQUED THE DRIVER AT AN ANGLE, CAUSING THE TIP TO BREAK.

    Description of Event or Problem · 1

    NOTE: A FULL AUDIT OF ALL LEGACY COMPLAINTS SINCE THE INCEPTION OF THE COMPANY (2007) WAS CONDUCTED TO ASSURE ANY NON-CONFORMITIES THAT MAY EXIST FROM EARLIER YRS WERE DISCOVERED AND PROPERLY DOCUMENTED AND ADDRESSED. DURING THE AUDIT THIS REPORTABLE EVENT WAS IDENTIFIED AND IS NOW BEING SUBMITTED. PREVIOUS PERSONNEL HAD DEEMED THIS A NON-REPORTABLE. THIS EVENT WAS TO BE REPORTED WITHIN 30 DAYS OF OCCURRING. WHILE IMPLANTING A PEDFUSE PEDICLE SCREW, THE SURGEON TORQUED THE PEDICLE SCREW DRIVER AT AN ANGLE CAUSING THE TIP OF THE DRIVER TO BREAK OFF WITHIN THE HEAD OF THE PEDICLE SCREW. THE INCIDENT OCCURRED ON THE LAST PEDICLE SCREW TO BE INSERTED FOR THE PROCEDURE AND THE SCREW WAS FULLY SEATED AT THE TIME. MAJORITY OF THE MATERIAL WITHIN THE HEAD OF THE SCREW WAS RECOVERED BY THE SURGEON; THIS ADDED ON TO TWO MINS TO SURGERY TIME. THE PEDICLE SCREW CONSTRUCT WAS COMPLETED BY SECURING A ROD AND LOCKING CAP OVER THE PEDICLE SCREW. THIS MDR IS BEING FILED TO ADDRESS THAT SOME MATERIAL WAS LEFT WITH THE HEAD OF THE PEDICLE SCREW, BUT IS SECURED BY A ROD AND LOCKING CAP AND CANNOT MIGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115328 PEDFUSE PEDICLE SCREW DRIVER PEDICLE SCREW DRIVER MNI SPINEFRONTIER SI80053 03239-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other