BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE BUL LOR 9X11X27, 5 DG

    MDR report key: 7731347 · Received July 30, 2018

    Report

    Report Number
    1526439-2018-50716
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 2, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034140087
    PMA / PMN Number
    K041722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    (B)(4). VISUAL EXAMINATION FOUND THAT THE CAGE THREADS WERE TORN. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE CAGE THREADS BECOMING TORN CANNOT BE POSITIVELY DETERMINED. HOWEVER, A POSSIBLE ROOT CAUSE MAY LIKELY BE THAT INADVERTENTLY CROSS THREADING OCCURRED BETWEEN THE CAGE AND CAGE INSERTER. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION 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

    DURING THE SURGERY PERFORMED ON (B)(4) 2018, IT WAS FOUND THAT THE CONCORDE BULLET ((B)(4)) GOT BROKEN AT THE SITE WHERE THE INSERTOR WAS ATTACHED AND RESULTED IN AN UNSUCCESSFUL INSERTION. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572302 CONCORDE BUL LOR 9X11X27, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 187827411 ARLDYL 10705034140087

    Patients

    Seq Age Sex Outcome Treatment
    1 Other