BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREMER 3D CROWN

    MDR report key: 388525 · Received April 4, 2002

    Report

    Report Number
    1526439-2002-00017
    Event Type
    Other
    Date Received
    April 4, 2002
    Report Date
    April 4, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    HAX
    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 SCREW JAMMED IN THE SCREW HOLE OF A BREMER HALO. ACCORDING TO THE COMPLAINANT, THE SCREW JAMMED AND THE HALO HAD TO BE REMOVED AND REPLACED WITH ANOTHER HALO. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER 3D CROWN CROWN HAX DEPUY ACROMED, INC. NA 044119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other