BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8X 28MM BIOABSORBABLE WEDGE INTERFERENCE SCREW

    MDR report key: 2143625 · Received June 3, 2011

    Report

    Report Number
    2936485-2011-00395
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE SCREW UNITS WERE IMPLICATED IN THIS EVENT, TWO SCREW UNITS FROM LOT 91705 AS WELL AS ONE SCREW UNIT FROM LOT 90903. ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW UNIT BROKE WHILE IMPLANTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8X 28MM BIOABSORBABLE WEDGE INTERFERENCE SCREW SCREW MAI STRYKER ENDOSCOPY SAN JOSE 91705

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR