BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 X 28MM BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 1172709 · Received September 18, 2008

    Report

    Report Number
    2936485-2008-00077
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HA/PLLA INTERFERENCE SCREW BROKE DURING SCREWING IN. THE DOCTOR INFORMED THAT THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 X 28MM BIOSTEON WEDGE INTERFERENCE SCREW BIOSTEON SCREW HWC STRYKER ENDOSCOPY SAN JOSE 0108PH31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK