BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 HOLE WIDE PLATE

    MDR report key: 6337769 · Received February 16, 2017

    Report

    Report Number
    3007420745-2017-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    December 14, 2016
    Report Date
    February 8, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    PMA / PMN Number
    K160177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A MALE IN HIS LATE 40'S, REPORTED PAIN IN HIS FOOT AROUND SURGICAL SITE POST-OPERATIVELY. (THIS PATIENT HAD AN MPJ FUSION SURGERY ON (B)(6) 2015) X-RAYS WERE TAKEN AND IT WAS DETERMINED THAT THE 300-50-004 PLATE WAS BROKEN AND A NON-UNION HAD OCCURRED. (SCREWS USED WITH THIS PLATE WERE 3.0 LOCKING SCREWS) FOLLOW UP WITH THE DOCTOR WAS PERFORMED BY THE SALES REP AND THE FOLLOWING INFORMATION WAS RELAYED BACK TO CORPORATE. THE SURGICAL TECHNIQUE WAS FOLLOWED. PARTS WERE NOT SENT BACK TO CORPORATE. THE 300-50-004 PLATE WAS REMOVED FROM THE PATIENT ON (B)(6) 2016 AND THE SURGEON USED A 4.0 MM TIGER CANNULATED SCREW TO FIXATE THE SITE. THE SURGEON CONFIRMED A NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120387 4 HOLE WIDE PLATE PLATE, FIXATION, BONE HRS TRILLIANT SURGICAL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention