BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM

    MDR report key: 15250098 · Received August 18, 2022

    Report

    Report Number
    1220246-2022-05408
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036534
    PMA / PMN Number
    K120148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN 1192-090 LAG SCREW BACKED OUT. THIS WAS DISCOVERED DURING AFTER THE SCREW WAS IMPLANTED FOR AN UNSPECIFIED TIME, A REVISION SURGERY IS PLANNED. REVISION DATE (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2461314 LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM 212113 00848665036534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other