BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREMER HALO SYSTEM

    MDR report key: 448491 · Received March 14, 2003

    Report

    Report Number
    1526439-2003-00018
    Event Type
    Other
    Date Received
    March 14, 2003
    Report Date
    March 14, 2003
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    KQZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HALO HAD TO BE REMOVED FROM A PATIENT AFTER TWELVE DAYS. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS PLACED IN THE HALO DUE TO A FRACTURED 2ND VERTEBRAE. DURING THE TWELVE DAYS, THE FRONT SCREWS CAME LOOSE FROM THE SKULL THREE SEPARATE TIMES. THESE FRONT SCREWS WERE THEN REMOVED, LEAVING ONLY THE SIDE SCREWS. A FEW DAYS LATER, THE HALO WAS REMOVED. THE COMPLAINANT BELIEVES THAT THE EVENT WAS CAUSED BY IMPROPER APPLICATION OF THE DEVICE. THE PART AND LOT NUMBERS WERE UNKNOWN AND THE PRODUCT WILL NOT BE RETURNED. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT. SINCE THE PRODUCT AND LOT INFORMATION WAS NOT KNOWN AND THE PRODUCT WILL NOT BE RETURNED, NO FURTHER EVALUATION CAN BE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other