BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD LAG SCREW OMEGA 115MM LENGTH

    MDR report key: 2140591 · Received June 16, 2011

    Report

    Report Number
    8031020-2011-00141
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K955306
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE END OF THE LAG SCREW WAS DAMAGED. THIS REQUIRED EXTRACTION OF THE DEVICE AND IMPLANTING ANOTHER DEVICE OF DIFFERENT LENGTH. THIS CAUSED THE SURGERY TIME TO BE EXTENDED. PATIENT HAD HARD BONE AND TAPPING WAS NOT PERFORMED BEFORE INSERTION OF LAG SCREW. ALSO, THE INSERTER DEVICE MIGHT HAVE BECOME LOOSE ALLOWING IT TO DAMAGE THE END OF THE LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD LAG SCREW OMEGA 115MM LENGTH IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA W03902

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other