BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE BALLOON/MEDIUM- STERILE

    MDR report key: 10284332 · Received July 16, 2020

    Report

    Report Number
    2939274-2020-03230
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 29, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRX
    UDI-DI
    10705034722719
    PMA / PMN Number
    K130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: NDN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, DURING A KYPHOPLASTY CASE, A SYNFLATE BALLOON HAD A HOLE IN IT. WHEN THE BALLOON WAS INSERTED INTO PATIENT, THE BALLOON LEAKED CONTRAST FLUID IN THE PATIENTS L1 VERTEBRAE. THE PATIENT WAS NOT ALLERGIC TO THE FLUIDS, THE FAILED BALLOON WAS REMOVED AND ANOTHER BALLOON WAS OPENED AND USED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SYNFLATE BALLOON/MEDIUM- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751093 SYNFLATE BALLOON/MEDIUM- STERILE ACCESSORIES, ARTHROSCOPIC HRX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.804.701S 10705034722719

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR