BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOTOME, OBSWEGESER INTERDENTAL, 3MM

    MDR report key: 5161446 · Received March 24, 2004

    Report

    Report Number
    8010177-2004-00003
    Event Type
    Injury
    Date Received
    March 24, 2004
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DEVICE BROKE AND WAS LEFT IN PATIENT, NOT TO BE DISCOVERED UNTIL POST SURGICAL MRI. REVISION SURGERY AND RETRIEVAL COMPLETED SUCCESSFULLY, PER REPORT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOTOME, OBSWEGESER INTERDENTAL, 3MM INTERDENTAL OSTEODOME HWM STRYKER INSTRUMENTS 01-17840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention