BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE BALLOON/MEDIUM-STERILE

    MDR report key: 3981222 · Received August 5, 2014

    Report

    Report Number
    3000270450-2014-10064
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NDN
    PMA / PMN Number
    PK130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED AND THE INVESTIGATION WAS COMPLETED BY THE SUPPLIER. THE DEVICE RECEIVED IN A PLASTIC BAG WAS REMOVED FROM THE ORIGINAL PACKAGING. THE SUPPLIER COULD NOT FIND ANY DEVIATION. THE MEASUREMENTS ARE IN THE TOLERANCES. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. T 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 THE SURGEON WAS NOT ABLE TO INTRODUCE OR ADVANCE TWO SYNFLATE BALLOONS DOWN THE WORKING CANNULA OF A CAVITY CREATION ACCESS KIT. DURING A UNILATERAL KYPHOPLASTY PROCEDURE AT L1, THE SURGEON WAS NOT ABLE TO INTRODUCE OR ADVANCE THE SYNFLATE BALLOON DOWN THE WORKING CANNULA OF A CAVITY CREATION ACCESS KIT. AFTER CHANGING BALLOONS AND HAVING THE SAME PROBLEM, THE SECOND BALLOON WAS FORCED DOWN THE CANNULA RESULTING IN BENDING THE WIRE OF THE KIT. THIS WAS AN OLD FRACTURE AND THE BALLOON WOULD NOT INFLATE PAST 2CC. THIS RESULTED IN A TWENTY-FIVE MINUTE DELAY. THE FINAL STEP WAS THE INSERTION OF THE VERTECEM CEMENT AFTER THE SECOND SYNFLATE BALLOON WAS REMOVED. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458540 SYNFLATE BALLOON/MEDIUM-STERILE POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES SELZACH 1113023

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR