BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM

    MDR report key: 5442679 · Received February 17, 2016

    Report

    Report Number
    2916714-2016-00056
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 17, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GXR
    PMA / PMN Number
    K040080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: ON-GOING

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN WHEN DEVICE WAS USED DURING SURGERY, THE THREAD WAS CUT OFF. SURGICAL DELAY OVER 15 MINUTES. PRODUCT WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99676 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM RESORBABLE IMPLANT FOR CRANIAL CLOSURE GXR AESCULAP AG FF016 52131907

    Patients

    Seq Age Sex Outcome Treatment
    1 Other