BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD RING DRIVE EXTEND/SHORT

    MDR report key: 4340634 · Received December 9, 2014

    Report

    Report Number
    1222895-2014-00032
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Report Date
    November 14, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    AFTER A CASE, IT WAS NOTICED THAT THE DEVICE WAS DEFECTIVE. THE JOINT BETWEEN THE TWO CIRCULAR PARTS WAS NOT COMPLETE. THE CUSTOMER DID NOT KNOW IF IT WAS USUALLY GLUED TOGETHER AND THE GLUE BROKE OR IF THE WELDING SEPARATED, BUT ALL THE OTHER HRDXS WERE FINE. IT WAS NOTED THAT THOSE EXTENDERS ARE USED ON SPECIFIC PATIENTS FOR BETTER POSITIONING. THE PRODUCT WAS NOT IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY. THERE WAS NO DELAY IN SURGERY. ADDITIONAL INFORMATION WAS REQUESTED AND ON 11/27/2014, THE FOLLOWING WAS PROVIDED BY THE REGIONAL SALES MANAGER. THE DEFECTIVE PRODUCT WAS NOTICED DURING INSPECTION SO ONCE THE CUSTOMER NOTICED IT, THEY PULLED OUT THE HRDXS AND DIDN'T USE IT ANYMORE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792613 HEAD RING DRIVE EXTEND/SHORT NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1