BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILINK - P

    MDR report key: 19904412 · Received August 5, 2024

    Report

    Report Number
    3012495575-2024-00001
    Event Type
    Injury
    Date Received
    August 5, 2024
    Manufacturer
    SURGENTEC, LLC
    Product Code
    OUR
    PMA / PMN Number
    K230857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A POSTERIOR TILINK CASE PERFORMED WITH THE 25MM SCREW, SCREW ANCHOR AND 5CC OSTEOFLO NANOPUTTY INSERTED ON (B)(6) 2024. THE PATIENT THEN DEVELOPED AN INFECTION AFTER THE SURGERY WAS PERFORMED, TIME OF INFECTION NOT DEFINED. AN EXPLANT OF THE IMPLANTED DEVICE TOOK PLACE ON (B)(6) 2024. THERE WAS NO REPORT OF A DEVICE OR ITS RELATED COMPONENTS MALFUNCTION OR FAILURE. IT WAS REPORTED THE SURGEON THAT THERE WAS POTENTIAL SANITARY ISSUES WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781040 TILINK - P TILINK - P OUR SURGENTEC, LLC TILINK-P 12X25MM SCREW A002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention