BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETENTION BONE-SCREW DRIVER

    MDR report key: 4722763 · Received April 21, 2015

    Report

    Report Number
    3005739886-2015-00040
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 31, 2015
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    K121172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: ENGINEERING EVALUATION DETERMINED THAT THE DRIVER WAS UTILIZED WITH A CUSTOM TAP THAT WAS 1MM UNDERSIZED, WHICH WOULD NOT HAVE SUFFICIENTLY PREPARED THE HOLE FOR THE BONE SCREW, MOST LIKELY CAUSING THE DRIVER TO EXPERIENCE AN EXCESSIVE TORQUE CONDITION, CONTRIBUTING TO ITS FAILURE. REVIEW OF MANUFACTURING HISTORY RECORDS FOUND A TOTAL OF (B)(4) PIECES OF LOT 0120IT WERE RELEASED FOR DISTRIBUTION ON JULY 8, 2014 WITH NO DEVIATION OR ANOMALIES. A TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT REVEAL ANY PREVIOUS REPORTS OF THIS NATURE OF THE REPORTED LOT. A TREND FOR REPORTS OF THIS NATURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2015, THE PEDICLE WAS PREPPED USING A CUSTOM 5.5MM TAP (C2114-55). SUBSEQUENTLY, UPON USING THE RETENTION BONE-SCREW DRIVER (39-SP-0601) TO ADVANCE THE 6.5 X 50MM REFORM POLYAXIAL SCREW INTO THE L5 PEDICLE FOR EASIER ROD PLACEMENT, THE TIP OF THE DRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE SCREW WAS REMOVED, THE PEDICLE RE-TAPPED WITH A LARGER TAP TO INCREASE THE PILOT HOLE DIAMETER AND A NEW 6.5 X 50MM REFORM POLYAXIAL SCREW WAS PLACED USING A CUSTOMER POLYAXIAL DRIVER WITH NO ADDITIONAL ISSUES. A DELAY TO THE PROCEDURE OF LESS THAN ONE MINUTE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262361 RETENTION BONE-SCREW DRIVER HXX PRECISION SPINE, INC. 0120IT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention