BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 3052019 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-01593
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE 510K# IS NOT AVAILABLE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE COMPLAINT WAS FORWARDED TO THE MANUFACTURER. ACCORDING TO THE PRESENT STATEMENT, THE CAUSE OF FAILURE COULD NOT BE DETERMINED. WE QUOTE FROM THE INVESTIGATION REPORT: IN OUR LABORATORY A BREAKAGE COULD ONLY IMITATED BY EXCESSIVE FORCE DURING APPLICATION. HIGH FORCES DURING THE TRANSFER OF THE CEMENT INTO THE SYRINGE SYSTEM CAN OCCUR IF THE POLYMERIZATION OF THE CEMENT IS WELL ADVANCED AND THE VISCOSITY HAS INCREASED SIGNIFICANTLY OF IF THE TRANSFER IN THE SYRINGE IS BLOCKED. IN THIS CASE THE AGITATOR AXIS CAN BREAK UPON FURTHER ACTUATION OF THE MIXER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHILE FILLING THE 2 ML SYRINGE, REPORTEDLY THE MIXING DEVICE BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156541 VERTECEM V+ CEMENT KIT NDN SYNTHES GMBH 1E53040

    Patients

    Seq Age Sex Outcome Treatment
    1