BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION SCREW

    MDR report key: 1905470 · Received November 10, 2010

    Report

    Report Number
    9610622-2010-00473
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    HEAD OF THEATRE, REPORTED, VIA SALES REP, THAT THE SURGEON WAS NOT ABLE TO SCREW IN THE SCREW. HE SAID THAT IT DOES NOT FIT. NO FURTHER INFO WERE GIVEN. THE SURGEON USED ANOTHER SCREW TO FINISH THE OPERATION. NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXATION SCREW INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K236106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other