BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY STENT-LARGE

    MDR report key: 11869803 · Received May 24, 2021

    Report

    Report Number
    8030965-2021-04165
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    UDI-DI
    07611819432628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: H3, H4, H6: PART # 09.804.502S; SYNTHES LOT # J002422; SUPPLIER LOT # 82207441; RELEASE TO WAREHOUSE DATE: NOVEMBER 30, 2020; SUPPLIER: CONFLUENT MEDICAL TECHNOLOGIES, COSTA RICA; NO NCR'S WERE GENERATED DURING PRODUCTION. VISUAL INSPECTION: VBS LARGE (PART# 09.804.502S, LOT# J002422, QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE BALLOON GOT FLATTENED. THERE IS A HIGH POSSIBILITY OF A VERY SMALL HOLE IN BALLOON. NO OTHER DEFECTS WERE IDENTIFIED WITH THE RETURNED DEVICE. THE STENT WAS NOT RETURNED AT CQ. FUNCTIONAL TEST: THE BALLOON WAS OBSERVED TO NOT INFLATE, MOST LIKELY DUE TO A SMALL HOLE/DAMAGE WITH UNKNOWN TIME ORIGIN. THE STENT WAS NOT RETURNED AND HENCE COULD NOT BE TESTED FOR FUNCTIONALITY. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? UNABLE TO PERFORM AS THE STENT WAS NOT RETURNED ALONG WITH THE DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT RELEVANT TO THE REPORTED FAILURE. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED: VBS CATHETER ASSEMBLY DEPUY SYNTHES NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS BEING CONFIRMED FOR THE VBS LARGE (PART# 09.804.502S, LOT# J002422) AS THE BALLOON GOT FLATTENED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED ISSUE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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. 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. H3, H6: 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SURGEON HAD ISSUES WHEN PLACING THE STENT. THE STENT CAME LOOSE FROM THE BALLOON AND IT COULD NOT BE OPENED. THE PATIENT IS DOING WELL AND THE PROCEDURE FINISHED WITHOUT ANY PROBLEMS. TWO MORE STENTS WERE PLACED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) VERTEBRAL BODY STENT-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768754 VERTEBRAL BODY STENT-LARGE POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH J002422 07611819432628

    Patients

    Seq Age Sex Outcome Treatment
    1