BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN LOW PROFILE SCREW 5.0MM X 80MM

    MDR report key: 6444473 · Received March 29, 2017

    Report

    Report Number
    1020279-2017-00230
    Event Type
    Injury
    Date Received
    March 29, 2017
    Report Date
    September 26, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSB
    PMA / PMN Number
    K111025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION. PLEASE SEE ATTACHED FOR INVESTIGATION RESULTS.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO A TRIGEN HFN CALC-CUBOID SCREW THAT HAD BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223995 TRIGEN LOW PROFILE SCREW 5.0MM X 80MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SMITH & NEPHEW, INC. 16ET69354

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R