BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORAGE STANDARD SCREW 3.5MM X 16MM STERILE

    MDR report key: 2940661 · Received December 12, 2012

    Report

    Report Number
    8031020-2012-00297
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    PMA / PMN Number
    K083447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SALES REP REPORTED ON BEHALF OF THE SURGEON THAT THE SCREW THREADED UPON IMPLANT INTO BONE AND PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORAGE STANDARD SCREW 3.5MM X 16MM STERILE IMPLANT LXH STRYKER OSTEOSYNTHESIS SELZACH NA 50024849 ASP DB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other