BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X10X23, 5 DG

    MDR report key: 7411969 · Received April 10, 2018

    Report

    Report Number
    1526439-2018-50332
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 14, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034139517
    PMA / PMN Number
    K041722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONCORDE BULLET 5 DEGREE LORDOTIC CAGE WAS NOT RETURNED TO THE CUSTOMER QUALITY UNIT FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CONCORDE BULLET 5 DEGREE LORDOTIC CAGE COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING PER WORK INSTRUCTION. WITHOUT THE RETURN OF THE CONCORDE BULLET CAGE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE. AS SUCH, NO FURTHER COMPLAINT ACTION IS REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON WAS TRYING TO PLACE A CAGE AT L5-S1 DISC SPACE. HE WAS COMING IN LATERALLY THEN PULLED HIS HAND DOWN WITH INSERTER TO DRIVE THE CAGE TO A MORE MIDLINE APPROACH AND THE CAGE BROKE OFF AT THE INSTRUMENT/CAGE INTERFACE. THIS HAPPENED WITH BOTH CAGES. THEN PROCEEDED TO USE THE DUAL PREP INSTRUMENT TO GET MORE MIDLINE AND THEN THE THIRD CAGE WAS PLACED TO HIS SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261154 CONCORDE BUL LOR 9X10X23, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 187823410 10705034139517

    Patients

    Seq Age Sex Outcome Treatment
    1