BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP® PROXIMAL HUMERUSPLATE-STANDARD 5H SHAFT/114MM

    MDR report key: 2870463 · Received December 12, 2012

    Report

    Report Number
    2520274-2012-03834
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 25, 2010
    Report Date
    January 17, 2011
    Manufacturer
    SYNTHES
    Product Code
    KTW
    PMA / PMN Number
    K011815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A PLATE BROKE POST-OPERATIVELY. X-RAYS WERE TAKEN. A HUMERAL FRACTURE WAS SEEN ON (B)(6) 2010. OSTEOSYNTHESIS ON (B)(6) 2010. FOLLOW UP CHECK UPS WERE FROM (B)(6) 2010. BREAKAGE OF PLATE OCCURRED ON (B)(6) 2010. REMOVAL OF THE BROKEN PLATE WAS ON (B)(6) 2010. THE NEW PLATE WAS IMPLANTED ON (B)(4) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI LCP® PROXIMAL HUMERUSPLATE-STANDARD 5H SHAFT/114MM 3.5MM TI LCP® PROXIMAL KTW SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention