BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARDINGE CEM REST INTRO LONG

    MDR report key: 4091328 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28121
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO PRODUCT LOT NUMBER WAS PROVIDED. WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCT THE ROOT CAUSE OF THE COMPLAINT CANNOT BE IDENTIFIED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND MONITORED THOUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE RE-OPENED AND INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    INSTRUMENT BROKE DURING SURGERY. NO REP WAS IN ATTENDANCE WHEN THIS HAPPENED AND HOSPITAL HAVE DISCARDED THE INSTRUMENT. NO DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573554 HARDINGE CEM REST INTRO LONG CEMENT / CEMENT ACCESSORY LXH DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1