BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORCORDE BUL LOR 11X10X31

    MDR report key: 4361673 · Received December 24, 2014

    Report

    Report Number
    1526439-2014-12272
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK041722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE DISCARDED.

    Description of Event or Problem · 1

    THE CONCORDE BULLET CAGE FRACTURED/SHATTERED UPON ATTEMPTED IMPACTION INTO THE DISC SPACE. SURGEON PROCEEDED BY REMOVING ALL THE FRAGMENTS FROM THE DISC SPACE, AND A NEW SAME LIKE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849818 CORCORDE BUL LOR 11X10X31 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1