BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LCP DISTAL FEMUR PLATE

    MDR report key: 3003425 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10358
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DHR REVIEW PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. RETURNED DEVICE WAS VISUALLY INSPECTED. THE DAMAGED PACKAGING WAS NOT RETURNED WITH THE DEVICE. DUE TO MISSING PACKAGING THIS COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN OUTER PACKAGING WAS OPENED IT WAS NOTED INSIDE PACKAGING FOR THE PLATE WAS OPEN AT ONE END. OUTER PACKAGE WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87002 TI LCP DISTAL FEMUR PLATE HRS SYNTHES GMBH 2587956

    Patients

    Seq Age Sex Outcome Treatment
    1