BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE LAG SCREW CONNECTOR

    MDR report key: 1850357 · Received September 20, 2010

    Report

    Report Number
    9610622-2010-00394
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 2, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    DURING G3 SURGERY, THE SURGEON PLACED THE U-LAG SCREW INTO THE PT. THE SURGEON TRIED TO INSERT THE U-BLADE USING THE INSERTER AND CONNECTER. THE SHAFT OF CONNECTER BROKE WHEN U-BLADE WAS INSERTED. THE SURGEON USED THE POWER TOOL TO REMOVE THE CONNECTER AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE LAG SCREW CONNECTOR INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K758144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other