BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL

    MDR report key: 24059565 · Received January 13, 2026

    Report

    Report Number
    3012120772-2025-00074
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 13, 2026
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    LXH
    UDI-DI
    10889981277109
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE REPORTER, THE TWO AP2-100506 TEMPORARY FIXATION PINS WERE DISCARDED. AS A RESULT, THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, NO LOT INFORMATION WAS PROVIDED. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS. INTRAOPERATIVE FISSURE, FRACTURE, OR PERFORATION OF THE SPINE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S ADMIRAL ACP SYSTEM. IT WAS REPORTED THAT TWO TEMPORARY FIXATION PINS (AP2-100506) FRACTURED AND THE TIPS WERE LEFT INSIDE THE PATIENT'S BONE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113828 ADMIRAL TEMPORARY FIXATION PIN LXH SEASPINE ORTHOPEDICS CORPORATION AP2-100506 10889981277109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other