BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP 10 MM, +2 MM

    MDR report key: 2583287 · Received May 11, 2012

    Report

    Report Number
    9610622-2012-00221
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 2, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSD
    PMA / PMN Number
    K011529
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT, "DURING A SURGICAL PROCEDURE OF HUMERAL OSTEOSYNTHESIS WHILE THE SURGEON WAS COMPLETING THE PROCEDURE THE PRODUCT FAILED TO ASSEMBLE WITH THE OTHER. THE SURGEON REPORTED THAT THE ENDCAP WAS TOO BIG. THE SURGEON COMPLETED SUCCESSFULLY THE PROCEDURE USING ANOTHER ITEM OF THE SAME SIZE BUT DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 END CAP 10 MM, +2 MM IMPLANT HSD STRYKER OSTEOSYNTHESIS KIEL NA K284104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other