BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2072645 · Received April 22, 2011

    Report

    Report Number
    2520274-2011-00120
    Event Type
    Injury
    Date Received
    April 22, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. DEVICE IMPLANTED APPROX 3 YEARS PRIOR TO EXPLANT DATE. SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH LISS PROXIMAL TIBIA PLATE, LISS DISTAL FEMUR PLATE AND SCREWS APPROX 3 YEARS PRIOR FOR A PROXIMAL TIBIA AND DISTAL FEMUR FRACTURE. STATUS POST, PT BEGAN EXPERIENCING DISCOMFORT FROM THE PLATES AND REQUESTED REMOVAL OF THE HARDWARE. X-RAYS TAKEN SHOWED FRACTURE HEALED. HARDWARE WAS REMOVED (B)(6) 2011. THIS IS THE 1ST OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI LISS PROXIMAL TIBIA PLATE HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE| SCREWS