BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANSSON PIN TI 95MM

    MDR report key: 2002972 · Received February 8, 2011

    Report

    Report Number
    8031020-2011-00026
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 23, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K033968
    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. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 8031020-2011-00025.

    Description of Event or Problem · 1

    ONE WEEK AFTER THE OPERATION, THE HOOK OF THE HANNSON PIN CAME OUT LATERALLY ABOUT 5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANSSON PIN TI 95MM IMPLANT HTY STRYKER OSTEOSYNTHESIS SELZACH NA T99443

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other