BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 16252343 · Received January 27, 2023

    Report

    Report Number
    8030965-2023-01043
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 5, 2023
    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, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 01 OCT 2021, SUPPLIER: (B)(4), EXPIRATION DATE: 01 OCT 2024. 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, A FOLLOW-UP WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE FOR AN L1 FRACTURE. WHEN THE CEMENT WAS MIXED AND ABOUT FIVE MINUTES HAD PASSED, THE CEMENT WAS NOT INJECTED INTO THE CEMENT SYRINGE AT ALL. THE SURGEON CHECKED THE CEMENT KIT, AND THERE WERE NO SIGNS OF CEMENT HARDENING YET. A NEW CEMENT KIT AND A NEW SYRINGE WERE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408723 VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH 1K53441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VERTECEM V+ SYRINGE KIT