BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP VOL-DIST-RADIUSPL2.4 R 5+4HO L65

    MDR report key: 3141260 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-02951
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K071184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE EVENT WAS CONFIRMED AND THE INITIAL INVESTIGATION REVEALED THAT WRONG ITEM WAS FOUND IN THE PACKAGE. CONCLUSION: WHILE IT MAY BE ASSUMED THAT THIS PARTICULAR ARTICLE WAS INADVERTENTLY PACKAGED WITHOUT HAVING GONE THROUGH THE PROPER CONTROLS, THE INVESTIGATION IS ONGOING AND NO CONCLUSION CAN BE DRAWN AT THIS POINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WRONG ITEM WAS PLACED INSIDE THE PART PACKAGE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244043 VA-LCP VOL-DIST-RADIUSPL2.4 R 5+4HO L65 PLATE, FIXATION, BONE HRS SYNTHES (USA) 5575089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown