BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE VERTEBRAL BALLOON LRG

    MDR report key: 3020513 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-01114
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    PMA / PMN Number
    K130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES BOTH COMPLAINED DEVICES SHOWED NO EVIDENT IRREGULARITIES WHICH COULD EXPLAIN ELEVATED PULLBACK FORCES. THE COMPLAINT CANNOT BE COMPREHENDED. THE COMPLAINED CATHETER BATCH UNDERWENT A DETAILED TECHNICAL ANALYSIS AND THE ASSOCIATING MANUFACTURING AND TEST DOCUMENTATION WAS CHECKED IN ORDER TO DETERMINE WHETHER A DEVIATION IN THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE FAILURE. THE REVIEW OF THE MANUFACTURING AND TEST DOCUMENTS ACCOMPANYING THE BATCH SHOWED NO NON CONFORMANCES IN RELATION TO THE OBSERVED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THIS REPORT IS FOR TWO (2) SYNFLATE VERTEBRAL BALLOON. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: A SYNFLATE VERTEBRAL BALLOONS , LARGE, WAS INSERTED INTO THE FIRST CANNULA WITH CORRECT EXPANSION. SURGEON COULD NOT REMOVE THE BALLOON. THE BALLOON TOGETHER WITH THE CANNULA WAS EVENTUALLY REMOVABLE. SURGEON TRIED AGAIN WITH ANOTHER LARGE BALLOON AND THE SAME THING HAPPENED. SURGEON THEN SELECTED A MEDIUM SIZED BALLOON AND THERE WAS A NOT PROBLEM WITH THE MEDIUM SIZE. THE OPERATION WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124466 SYNFLATE VERTEBRAL BALLOON LRG NDN SYNTHES GMBH 1012016

    Patients

    Seq Age Sex Outcome Treatment
    1