BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X8X23, 5 DG

    MDR report key: 10747509 · Received October 28, 2020

    Report

    Report Number
    1526439-2020-02048
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034139494
    PMA / PMN Number
    K151773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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. H10: ADDITIONAL NARRATIVE: H6. 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: H3, H4, H6: THE DEVICE HISTORY RECORD (DHR) OF PRODUCT CODE 187823408, LOT 215725, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON SEPTEMBER 20, 2018. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, IT IS OBSERVED THAT THE RECEIVED DEVICE GOT BROKEN INTO 2 PIECES. BROKEN PIECE WAS RETURNED. THUS, THE COMPLAINT IS BEING CONFIRMED. DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED, AND THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION. THE RELEVANT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION; NO DESIGN ISSUES OR DISCREPANCIES WERE NOTICED. THE COMPLAINT CONDITION IS CONFIRMED. WHILE A DEFINITIVE ROOT CAUSE FOR THE REPORTED PROBLEM CANNOT BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED UPON THESE RESULTS, 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. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED 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 · 1

    ADDITIONAL PROCODE: MQP. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING A REVISION SURGERY TO A PREVIOUSLY FUSED LUMBAR SPINE. THIS CASE IS A T12-L3 FUSION WITH EXPEDIUM AND CONCORDE BULLET (CFRP) TLIF AT T12/L1. THE CAGE WAS A CFRP CONCORDE BULLET 8MM LORDOTIC. THE SURGEON ASKED THE FELLOW TO ADJUST THE INSERTER LATERALLY AS HE ADVANCED THE CAGE TO GET THE CAGE TO THE DESIRED POSITION IN THE DISC SPACE. AFTER THE FIRST STRIKE WITH THE MALLET, THE FELLOW ATTEMPTED TO ADJUST TO CAGE LATERALLY. TOO MUCH FORCE WAS APPLIED AND THE CAGE BROKE. THE CAGE WAS REMOVED EASILY. ANOTHER 8MM CAGE WAS USED AND IMPLANTED SUCCESSFULLY WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A CONCORDE CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211460 CONCORDE BUL LOR 9X8X23, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 187823408 215725 10705034139494

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INSERTION INSTRUMENTS| UNKNOWN INSERTION INSTRUMENTS