BEUDAMED
    FDA Adverse Event Death Summary report: N

    TILINK-P SCREW 12MM X 25MM

    MDR report key: 22019293 · Received May 14, 2025

    Report

    Report Number
    3012495575-2025-00003
    Event Type
    Death
    Date Received
    May 14, 2025
    Date of Event
    April 11, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SURGENTEC, LLC
    Product Code
    OUR
    UDI-DI
    00810131880842
    PMA / PMN Number
    K242141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CASE WAS ON (B)(6) 2025 AT 7:30 AM. REP STATED THAT IT WAS A ROUTINE CASE. REP ALSO STATED THERE WAS MINOR BLEEDING THAT OCCURRED DURING THE SURGERY, AND THEY HAD IT UNDER CONTROL IN LESS THAN A MINUTE. REP ALSO STATED THAT NO SURGENTEC INSTRUMENTS WERE FAULTY OR HAD ANY ISSUES PRIOR TO OR DURING THE CASE. THE PATIENT DID NOT STAY UNDER ANESTHESIA LONGER THAN ORIGINALLY ANTICIPATED. THE REP THEN STATED THAT THE PATIENT STOOD UP 6.5 HOURS POST-OP AND EXPERIENCED A VASCULAR ISSUE. THE PATIENT THEN ULTIMATELY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329258 TILINK-P SCREW 12MM X 25MM SMOOTH OR THERADED METALLIC BONE FIXATION FASTENER OUR SURGENTEC, LLC S005 00810131880842

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death