BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE DOWEL

    MDR report key: 1637330 · Received March 17, 2010

    Report

    Report Number
    MW5015220
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 17, 2010
    Manufacturer
    ALOSOURCE
    Product Code
    MQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BONE DOWELL IMPLANTED IN PT BY NEUROSURGEON. BONE DOWELL DISINTEGRATED INTO PIECES WHILE BEING IMPLANTED. DOSE: 1.25MM X 1.12MM. DATES OF USE: (B) (6) 2010. DIAGNOSIS: CERVICAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE DOWEL BONE DOWEL WITHOUT CARTILAGE, 12MM MQY ALOSOURCE 092159-114

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability