BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 4183153 · Received October 17, 2014

    Report

    Report Number
    8030965-2014-01403
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURE WAS IDENTIFIED. THE DEVICE WAS SENT BACK TO THE CUSTOMER ON (B)(4) 2013. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING THE PROCEDURE THE ENGINE LOSES STRENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660094 CAD II HWE SYNTHES GMBH 25417

    Patients

    Seq Age Sex Outcome Treatment
    1