BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM 5 HOLE VLC GRIDLOCK PLATE

    MDR report key: 7119758 · Received December 14, 2017

    Report

    Report Number
    3007420745-2017-00017
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 13, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    UDI-DI
    00812926025346
    PMA / PMN Number
    K130964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ONE OF TRILLIANT'S SALES REPRESENTATIVES WAS INFORMED BY (B)(6) HOSPITAL THAT A 300-50-008 PLATE WAS BROKEN IN A PATIENT THAT HAD UNDERGONE SURGERY ON (B)(6) 2017. THE PATIENT CAME IN FOR POST-OP VISIT (2-3 WEEKS AFTER THE SURGERY). AT THIS TIME, THE SURGEON NOTICED SOME SWELLING AND AFTER TAKING X-RAYS NOTICED THE PLATE WAS BROKEN. THE 300-50-008 PLATE WAS REMOVED FROM THE PATIENT ON (B)(6) 2017 DURING A REVISION CASE AS A FUSION HAD NOT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898980 CUSTOM 5 HOLE VLC GRIDLOCK PLATE BONE PLATE HRS TRILLIANT SURGICAL, LTD 300-50-008 TSL004426 00812926025346

    Patients

    Seq Age Sex Outcome Treatment
    1