BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE VERTEBRAL BALLOON MED

    MDR report key: 19609879 · Received June 25, 2024

    Report

    Report Number
    8030965-2024-07884
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 29, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    UDI-DI
    07611819525399
    PMA / PMN Number
    K130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. D2B.: ADDITIONAL PRO-CODE: NDN. E3: REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY 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 H3, H4, H6: DEVICE HISTORY LOT PART #03.804.701S SYNTHES LOT # 82283830 SUPPLIER LOT# 82283830 RELEASE TO WAREHOUSE DATE:14 JULY 2023 SUPPLIER: (B)(4), NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (FUSION COMBINED) FOR OSTEOPOROTIC VERTEBRAL FRACTURE ON (B)(6) 2024, WITH SYNFLATE. IN THE SURGERY, THE SURGEON PLACED THE BALLOON IN QUESTION INTO THE VERTEBRAL BODY AFTER NEGATIVE PRESSURE. SUBSEQUENTLY, THE DILATANT CAME OUT FROM THE TIP SLIGHTLY ABOVE THE CONNECTION BETWEEN THE INFLATION AND THE BALLOON, AND THE DILATANT COULD NOT BE DELIVERED INTO THE VERTEBRAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME AND NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SYNFLATE BALLOON/MEDIUM- STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697076 SYNFLATE VERTEBRAL BALLOON MED CEMENT, BONE, VERTEBROPLASTY NDN SYNTHES GMBH 82283830 07611819525399

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SYNFLATE VERTEBRAL BALLOON MED