BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACE HALO SYSTEM

    MDR report key: 382309 · Received March 12, 2002

    Report

    Report Number
    1526439-2002-00012
    Event Type
    Other
    Date Received
    March 12, 2002
    Date of Event
    February 1, 2002
    Report Date
    March 12, 2002
    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 A HALO RING BROKE DURING POST APPLICATION OF THE RING. THE RING BROKE ON ONE SIDE OF THE HEAD AND PULLED OUT OF POSITION. ANOTHER RING AND 6 PINS HAD TO BE APPLIED ONCE THE BROKEN RING WAS REMOVED. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE HALO SYSTEM HALO KQZ DEPUY ACROMED, INC. NA 042048

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other