BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREMER HALO SYSTEM

    MDR report key: 364193 · Received December 5, 2001

    Report

    Report Number
    1526439-2001-00060
    Event Type
    Other
    Date Received
    December 5, 2001
    Report Date
    December 5, 2001
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    KQZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT THE SECURING THREADED KNOBS ON THE LATERAL PORTION OF THE HALO WERE BROKEN, CAUSING THE HALO TO LOOSEN. ACCORDING TO THE COMPLAINTANT, THIS BREAK OCCURRED ELEVEN DAYS AFTER INITIAL APPLICATION. THE PATIENT'S SPINE WAS STABILED AND ANOTHER HALO WAS APPLIED. A COMPLAINT HISTORY WAS PERFORMED AND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PART NUMBER. A DIMENSIONAL ANALYSIS WAS PERFORMED AND THE HALO CONFORMED TO SPECIFICATIONS. AND EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED, IT IS POSSIBLE THAT THE HALO SECURING SCREW COULD HAVE BEEN OVER-TORQUED DURING APPLICATION, CAUSING THE KNOB TO FRACTURE. THE MATERIAL OF THE THREADED SECURING KNOBS IS BEING CHANGED FROM PLASTIC TO ALUMINUM. THIS WILL INCREASE THE STRENGTH AND DURABILITY OF THE KNOBS, AND SHOULD PREVENT THIS TYPE OF EVENT FROM RECURRING. NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54711 BREMER HALO SYSTEM PEDIATRIC HALO KQZ DEPUY ACROMED, INC. NA 043136

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other