BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 16869596 · Received May 4, 2023

    Report

    Report Number
    8030965-2023-05761
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 20, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    UDI-DI
    07611819376250
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: INITIAL REPORTER FACILITY NAME: SPECIFIED MEDICAL CORPORATION (B)(6) HOSPITAL. E3: REPORTER IS A J&J EMPLOYEE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A VERTEBROPLASTY WAS PERFORMED ON (B)(6)2023, AND THE BALLOON BROKE DURING INFLATION. INTERNAL PRESSURE OF THE VERTEBRAL BODY AND HE AMOUNT OF CONTRAST AGENT ARE UNKNOWN. SINCE THE CONTRAST AGENT LEAKED INTO THE VERTEBRAL BODY, THE SURGEON WASHED IT USING SALINE. THE SURGEON CONFIRMED THAT THERE WAS NO RESIDUAL CONTRAST AGENT AND INJECTED THE CEMENT. AFTER 2 CC OF CEMENT WAS INJECTED TO BOTH SIDE, 1 CC OF THE CEMENT WAS INJECTED ADDITIONALLY. WHEN THE SURGEON INJECTED THE ADDITIONAL 1CC OF CEMENT, LEAKAGE OF THE CEMENT IN THE DIRECTION OF THE PEDICLE WAS CONFIRMED, AND THE SURGEON STOPPED INJECTING THE ADDITIONAL CEMENT. AFTER CEMENT HARDENING WAS CONFIRMED, THE SURGEON CLOSED THE WOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, LEAKAGE OF THE CEMENT WAS FOUND INSIDE THE PEDICLE AND ANTERIOR TO THE VERTEBRAL BODY ON A CT SCAN. THE PATIENT¿S CONDITION IS FINE. THIS REPORT INVOLVES ONE VERTECEM V+ CEMENT KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715291 VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH 07611819376250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VBS W/BALLOON SM