BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 3142128 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-02698
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    January 24, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    PMA / PMN Number
    K090432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE VERTECEM V+ CEMENT KIT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THERE IS NO PRODUCT ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VERTECEM V + DID NOT HARDEN IN-SITU WITHIN THE ADVISED TIME IN THE IFU. THE CEMENT MIGRATED AFTER FINISHING THE PROCEDURE. IT MIGRATED INTO THE PEDICAL WHERE THE NEEDLES WERE PLACED BEFORE. NO CLINICAL PROBLEM WAS DETECTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244432 VERTECEM V+ CEMENT KIT NDN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1