BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE INSERTER

    MDR report key: 2100191 · Received May 13, 2011

    Report

    Report Number
    9610622-2011-00220
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 28, 2011
    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

    ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    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. THE INSERTER BROKE WHEN U-BLADE HAD BEEN INSERTED BY USING INSERTER. HOWEVER, THE SURGEON CONTINUED USING THE INSERTER, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE INSERTER INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K178772

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other