BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VBS W/BALLOON SM

    MDR report key: 12274231 · Received August 4, 2021

    Report

    Report Number
    8030965-2021-06401
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    UDI-DI
    07611819471849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 09.804.600S SYNTHES LOT # J002434 , SUPPLIER LOT # 82213553, RELEASE TO WAREHOUSE DATE: (B)(6) 2021, EXPIRATION DATE: 01FEB2024, SUPPLIER: (B)(4). NON-CONFORMANCE REPORT (NCR) WAS GENERATED DURING DATA PARAMETER NOT RECORDED ¿ DOCUMENTAL ISSUE. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE ADVERSE IMPACT IN THE PRODUCT DUE TO DATA PARAMETER NOT RECORDED, SINCE THE PROCESS HAVE INSPECTION CONTROLS IN PLACE THAT ENSURE THAT THE PRODUCT MET THE SPECIFICATION, ALSO THE LINE CLEARANCE RECORDS AND EQUIPMENT RECORDS SUPPORTS THAT THE OPERATION PARAMETER WAS EXECUTED CORRECTLY. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PERCUTANEOUS VERTEBROPLASTY AT L1 PERFORMED ON (B)(6)2021, THE SURGEON INFLATED THE STENT VERY CAREFULLY. THE CONTRAST MEDIUM REACHED 3ML AND THE PRESSURE MEASURED 20ATM. THE SURGEON CONTINUED INFLATION FURTHER. THEN, THE MEDIUM SOLUTION AND PRESSURE SUDDENLY DROPPED BEFORE THEY REACHED THE MAXIMUM. IT WAS FOUND THAT THE MEDIUM CONTRAST HAD LEAKED FROM THE TIP OF THE BALLOON. THE DEVICES WILL NOT BE RETURNED SINCE THE THEY WERE USED FOR THE PATIENT WITH INFECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VBS W/BALLOON SM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170357 VBS W/BALLOON SM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH J002434 07611819471849

    Patients

    Seq Age Sex Outcome Treatment
    1