BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 12 HOLES/180MM/LEFT

    MDR report key: 3831547 · Received May 25, 2014

    Report

    Report Number
    3003506883-2014-10056
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    April 30, 2010
    Report Date
    April 30, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK011978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PART/CATALOG AND LOT NUMBER UNABLE TO BE VERIFIED. UNABLE TO VERIFY 510K INFORMATION WITHOUT PART/CATALOG NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL DOWN THE STAIRS ON (B)(6) 2010 AND SUFFERED A SHATZKER FRACTURE. THE SURGEON ATTEMPTED TO IMPLANT A PLATE BUT WAS UNABLE TO DUE TO THE FIT OF THE LOCKING SCREWS BEING TOO DISTAL OF A FIT WITH THE RAFT JOINT. THE SURGEON PERFORMED THE FIXATION WITH A 1/3 TUBULAR PROXIMAL TO TIBIA PLATE IN ORDER TO SUPPORT THE ELEVATED JOINT AND GRAFT; THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309753 3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 12 HOLES/180MM/LEFT PLATE, FIXATION, BONE HRS SYNTHES (USA) 6300433

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR