BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPPED MPJ VLC GRIDLOCK PLATE, RIGHT

    MDR report key: 6337805 · Received February 16, 2017

    Report

    Report Number
    3007420745-2016-00003
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    June 10, 2016
    Report Date
    December 6, 2016
    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

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DR. (B)(6) NOTIFIED REP, (B)(6), OF A BROKEN 1ST MPJ PLATE. ACCORDING TO DR. (B)(6), THE PATIENT ISN'T THE MOST COMPLIANT PATIENT AND MISSED A FEW FOLLOW UP APPOINTMENTS. THE PATIENT CAME FOR A FOLLOW UP AFTER EXPERIENCING SOME PAIN (ALMOST 2 MONTHS POST-OP) WHEN DR. (B)(6) TOOK X-RAYS TO DISCOVER THE BROKEN PLATE. THE REP FOLLOWED UP WITH THE DOCTOR TO CONFIRM THAT THE PLATE WAS NOT BENT OR MANIPULATED IN ANY WAY PRIOR TO PLACING PLATE FOR IMPLANTATION THE INITIAL CASE. NO INTERFRAG WAS USED FOR THE FUSION. DR. (B)(6) REMOVED THE PLATE AND SCREWS (ON (B)(6) 2016) AND DID NOT IMPLANT ANOTHER PLATE OR ANY OTHER HARDWARE. THE PATIENT WANTED TO KEEP THE PLATE AND SCREWS SO WE WON'T BE RECEIVING ANYTHING BACK. THE SURGEON NOTED THAT HE DIDN'T NOTIFY THE REP ASAP BECAUSE HE WASN'T CONCERNED AND HAS SEEN OTHER COMPETITOR'S PLATES BREAK BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120618 STEPPED MPJ VLC GRIDLOCK PLATE, RIGHT PLATE, FIXATION, BONE HRS TRILLIANT SURGICAL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention