BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

    MDR report key: 3171622 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02952
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    October 31, 2011
    Report Date
    December 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS FOR THE BELOW LISTED ARTICLES SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS. THE DEVICE WAS UNABLE TO BE EVALUATED AND NO CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2011, THE SCREW RAN THROUGH THE PLATE HOLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272470 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA HRS SYNTHES GMBH 7579417

    Patients

    Seq Age Sex Outcome Treatment
    1