BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERAL NAIL, CANNULATED, LEFT 8 X 150 M

    MDR report key: 1944729 · Received December 9, 2010

    Report

    Report Number
    9610622-2010-00525
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 25, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K042396
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY WITH THE T2 PH NAIL. ON (B)(6) 2010, WHEN THE SURGEON CONFIRMED X-RAY, IT WAS FOUND THAT THE SECOND SCREW FROM THE PROXIMAL NAIL BACKED OUT. THE SURGEON IS NOT PLANNING TO REMOVING THE NAIL YET. THE SURGEON IS MONITORING FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMAL HUMERAL NAIL, CANNULATED, LEFT 8 X 150 M IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other