BEUDAMED
    FDA Adverse Event Summary report: N

    TIGER HEADLESS CANNULATED SCREWS

    MDR report key: 5484959 · Received March 7, 2016

    Report

    Report Number
    3007420745-2016-00001
    Date Received
    March 7, 2016
    Date of Event
    February 8, 2016
    Report Date
    March 7, 2016
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HWC
    PMA / PMN Number
    K112737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTED TO CONTACT FACILITY REGARDING FACILITY INVESTIGATION RESULTS. NO RESPONSE RECEIVED AS OF 03/07/2016. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON (B)(6) 2016 WITH FOUR SCREWS. ON (B)(6) 2016 TRILLIANT WAS NOTIFIED THAT THE PATIENT SCHEDULED FOR EXPLANTATION DUE TO REPORTED INFLECTION. IMPLANTATION WAS PERFORMED AT (B)(6) AND THE SCHEDULED REMOVAL WAS AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141338 TIGER HEADLESS CANNULATED SCREWS BONE SCREWS OF LENGTH (10, 14 AND 20 MM) HWC TRILLIANT SURGICAL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention