BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PETITE STEPPED MPJ VLC GRIDLOCK PLATE, LEFT

    MDR report key: 7123137 · Received December 15, 2017

    Report

    Report Number
    3007420745-2017-00016
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 12, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    UDI-DI
    00812926025360
    PMA / PMN Number
    K130964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TRILLIANT SALES REPRESENTATIVES WAS INFORMED BY THE SURGERY CENTER AT (B)(6) THAT A 300-52-005 PLATE WAS BROKEN IN A PATIENT THAT HAD UNDERGONE SURGERY ON (B)(6) 2017. A FUSION DID NOT OCCUR AND THE PLATE WILL BE REMOVED FROM THE PATIENT ON (B)(6) 2017. FOLLOW UP WITH THE SURGEON BY THE SALES REPRESENTATIVE, THE SURGEON SUSPECTS THE PLATE BREAKAGE WAS DUE TO PATIENT NON-COMPLIANCE AND/OR TRAUMA. THE PATIENT CAME INTO THE SURGEON'S OFFICE EXPERIENCING PAIN. THE PATIENT HAS A RATHER LARGE DOG AND THE PATIENT REPORTED THAT THE DOG HAD POUNCED OR SAT ON THE PATIENT'S FOOT AND SHORTLY AFTER THAT SHE BEGAN TO EXPERIENCE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900292 PETITE STEPPED MPJ VLC GRIDLOCK PLATE, LEFT BONE PLATE HRS TRILLIANT SURGICAL, LTD 300-52-005 TSL004292 00812926025360

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention