BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL PLATE, DISTAL LATERAL NUMELOCK II FOR RIG

    MDR report key: 1903364 · Received November 10, 2010

    Report

    Report Number
    8031020-2010-00153
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 22, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K041709
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RISK MANAGER FROM THE HOSPITAL REPORTED THE FOLLOWING EVENT: A PLATE WAS IMPLANTED ON THE (B)(6) 2010. ON THE 11TH OCT, THE PATIENT HAD A REVISION AS THE PLATE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL PLATE, DISTAL LATERAL NUMELOCK II FOR RIG IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA U30611

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention