BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-ADAPTOR CLAMP, BLUE MONOTUBE TRIAX 20MM

    MDR report key: 2035236 · Received February 23, 2011

    Report

    Report Number
    8031020-2011-00048
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JFC
    PMA / PMN Number
    K936124
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HEAD OF MATERIALS ADMINISTRATION, REPORTED VIA OUR SALES REP THAT THE ADAPTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-ADAPTOR CLAMP, BLUE MONOTUBE TRIAX 20MM IMPLANT JFC STRYKER OSTEOSYNTHESIS SELZACH NA J323736

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other