BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHRONOS BETA-TCP STRIP 50MMX25MMX3MM-TRAINING ALL

    MDR report key: 2760733 · Received September 20, 2012

    Report

    Report Number
    1719045-2012-00972
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    August 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DURING A 2 LEVEL POST-LEVEL LUMBAR FUSION PROCEDURE, HE REALIZED HIS CHRONOS PACKAGE HAD A BLACK SPOT ON IT, MEANING IT WAS IN MORE THAN 40 DEGREES TEMP. THE CHRONOS PACKAGE WAS UNUSABLE, WAS NEVER OPENED AND DISCARDED. THE SURGEON USED ANOTHER CHRONOS PACKAGE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHRONOS BETA-TCP STRIP 50MMX25MMX3MM-TRAINING ALL CHRONOS BETA-TCP STRIP MQV SYNTHES MONUMENT N00373

    Patients

    Seq Age Sex Outcome Treatment
    1