BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM LEFT-STERILE

    MDR report key: 2870813 · Received December 12, 2012

    Report

    Report Number
    2520274-2012-03741
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 14, 2010
    Report Date
    December 16, 2010
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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 BROKEN LOCKING COMPRESSION PLATE. A 9 HOLE LOCKING COMPRESSION PLATE DISTAL FEMUR PLATE FAILURE AT POST LATERAL CLOSING WEDGE OSTEOTOMY WITH AUTOGRAFT. PRIOR TO THE LATE FAILURE, IMAGING LOOKED GOOD AND THERE WAS UNION. THE PATIENT WAS TOLD TO INCREASE ACTIVITY AND PARTIAL WEIGHT BEARING. PLATE BROKE AT SECOND MOST PROXIMAL ROW OF DISTAL LOCKING ONLY HOLES. THE LOCKING SCREWS IN SITU, THE LOCKING SCREW IN THE MOST PROXIMAL LOCKING HOLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM LEFT-STERILE LCP(TM) DISTAL FEMUR PLATE HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention