BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 16008841 · Received December 19, 2022

    Report

    Report Number
    8030965-2022-11282
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 29, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART: 07.702.016S. LOT : 1K53441. RELEASE TO WAREHOUSE DATE: 01.10.2021. EXPIRATION DATE : 01.10.2024. SUPPLIER: (B)(4). MANUFACTURING SITE: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERCUTANEOUS VERTEBROPLASTY (TH12) FOR OVF ON (B)(6) 2022. THE EVENTS TOOK PLACE IN SEQUENCE AS FOLLOWS: ALL THE MONOMER LIQUID WAS POURED INTO THE MIXER. THE SURGEON MIXED WITH THE MIXER FOR 20 SECONDS AND TURNED THE MIXER HANDLE CLOCKWISE UNTIL THE CEMENT WAS PUSHED UP INTO THE STOPCOCK. AFTER PREPARING THE INFLATION SYSTEM, THE SURGEON TRIED TO INJECT THE CEMENT INTO THE SYRINGE. ALTHOUGH THE SURGEON TURNED THE MIXER HANDLE, THE CEMENT WAS NOT INJECTED INTO THE SYRINGE. EVEN THOUGH THE SURGEON PULLED THE SYRINGE PUSHER, THE CEMENT WAS NOT INJECTED INTO THE CEMENT. THE SURGEON USED THE OTHER SYRINGE; HOWEVER, THE CEMENT WAS NOT INJECTED INTO THE CEMENT. THE SALES REP CHECKED THE MIXER HANDLE, AND IT WAS STIFFER THAN NORMAL AND COULD NOT BE TURNED. THE SURGEON COMMENTED THAT THE CEMENT VISCOSITY WAS HIGHER THAN THE ELAPSED TIME. A NEW CEMENT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VERTECEM V+ CEMENT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084694 VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH 1K53441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown