BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H+PIECE F/PIEZOELECTRIC SYSTEM

    MDR report key: 4136002 · Received October 2, 2014

    Report

    Report Number
    8030965-2014-01503
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    May 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDX
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(4) SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. 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. THE DEVICE WAS RETURNED, THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. AN ASSIGNABLE ROOT CAUSE IS UNDETERMINED. DEVICE WAS SENT TO (B)(4) FOR REPAIR ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE HEATED UP WHILE WORKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616062 H+PIECE F/PIEZOELECTRIC SYSTEM JDX SYNTHES GMBH 205515.003

    Patients

    Seq Age Sex Outcome Treatment
    1