BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INFINITY SKULL CLAMP

    MDR report key: 3960769 · Received June 10, 2014

    Report

    Report Number
    3004608878-2014-00075
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K051440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, METAL POWDER AT THE TORQUE SCREW WAS FOUND WHEN PRESSURE WAS APPLIED. THE PRODUCT PROBLEM WAS FOUND DURING THE INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR. THERE WAS NO PATIENT CONTACT AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337210 STANDARD INFINITY SKULL CLAMP NA HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1