BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 4101595 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-01148
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS 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. PMA/510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURE MODE/DEFECT WAS FOUND. THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(6), 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE GETS UNUSUALLY HOT. DEVICE WAS RETURNED FOR SERVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584345 COLIBRI HWE SYNTHES GMBH 2554

    Patients

    Seq Age Sex Outcome Treatment
    1