BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL DRIVER, REFORM

    MDR report key: 3962709 · Received July 15, 2014

    Report

    Report Number
    3005739886-2014-00035
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 20, 2014
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER SERIOUS: RETAINED FOREIGN OBJECT AS TIP OF DRIVER REMAINS IN THE HEAD OF THE SCREW IMPLANTED IN THE PATIENT. INVESTIGATION IS IN PROCESS BUT NOT YET COMPLETE. INITIAL INFORMATION PROVIDED INDICATES THAT THE DEVICE WILL BE RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2014, WHILE INSERTING THE REFORM PEDICLE SCREW IN THE LUMBAR SPINE, THE TIP OF THE POLYAXIAL DRIVER BROKE. THE SCREW WAS ALMOST COMPLETELY SEATED AND THE ROD AND CAP SCREW WERE INSERTED AND FINALLY TIGHTENED WITHOUT ISSUE. THE TIP OF THE SCREW REMAINS IN THE HEAD OF THE SCREW IMPLANTED IN THE PATIENT. NO DELAY OR INJURY TO THE PATIENT WAS REPORTED. INFORMATION PROVIDED INDICATES THAT THE SURGEON BELIEVED THAT THE DRIVER WAS NOT FULLY ENGAGED IN THE SCREW, CAUSING THE TIP TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412392 POLYAXIAL DRIVER, REFORM SCREWDRIVER HXX PRECISION SPINE, INC. 3155MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R