BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X8X27, 5 DG

    MDR report key: 15121614 · Received July 28, 2022

    Report

    Report Number
    1526439-2022-01294
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 27, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034140056
    PMA / PMN Number
    K173787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL PRODUCT CODE: SYNTHES COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9, H3, H6: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 187827408. LOT NUMBER: 339146. IT WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 11/03/2022. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT CONCORDE BUL LOR 9X8X27, 5 DG HAS BROKEN, THE BROKEN FRAGMENT WAS NOT RETURNED. NO OTHER PROBLEMS WERE OBSERVED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE CONCORDE BUL LOR 9X8X27, 5 DG DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO EXCESSIVE/UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CONCORDE BUL LOR 9X8X27, 5 DG WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT AFTER INITIAL PLACEMENT OF THE CAGE THE POSITION HAD TO BE CHANGED AGAIN AND DURING REMOVAL THE CAGE FRACTURED INTO TWO PARTS. IT IS UNCLEAR WHETHER THE CAGE ALREADY FRACTURED DURING INSERTION. NO SURGICAL DELAY, NO PATIENT HARM REPORTED. NO FRAGMENT REMAINED IN PATIENT´S BODY. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) CONCORDE BUL LOR 9X8X27, 5 DG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286198 CONCORDE BUL LOR 9X8X27, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 187827408 339146 10705034140056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown