BEUDAMED
    FDA Adverse Event Injury Summary report: N

    40MM ACUTRAK® 6/7 FIXATION SCREW

    MDR report key: 2140028 · Received June 25, 2011

    Report

    Report Number
    3025141-2011-00022
    Event Type
    Injury
    Date Received
    June 25, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K944330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ASSOCIATED MDR'S 3025141-2011-00020 AND 3025141-2011-00021.

    Description of Event or Problem · 1

    A 30.0MM ACUMED ACUTRAK 2 5.5 SCREW, A 35.0MM ACUMED ACUTRAK 2 SCREW AND A 40MM ACUTRAK 2 6/7 SCREW WERE IMPLANTED IN THE PATIENT'S HIP. THE PATIENT HAD COMPLICATIONS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 40MM ACUTRAK® 6/7 FIXATION SCREW SCREW, FIXATION, BONE HWC ACUMED LLC AP-6740-S W74248

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention