BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEO-CLAGE

    MDR report key: 122634 · Received September 25, 1997

    Report

    Report Number
    3025141-1997-00006
    Event Type
    Injury
    Date Received
    September 25, 1997
    Report Date
    September 24, 1997
    Manufacturer
    ACUMED, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BONEPLATE BENT WHILE IN PT. THIS IMPLANT WAS EXPLANTED. SALES REP SUSPECTED THAT BONEPLATE WAS SUBJECT TO EXTREME WEIGHT BEARING LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEO-CLAGE Implant BONEPLATE HRS ACUMED, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention