BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2 - TARGETING ARM

    MDR report key: 24835634 · Received April 9, 2026

    Report

    Report Number
    0008031020-2026-00546
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 9, 2026
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    04546540379658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: ¿DURING A T2 PHN SURGERY, THE SURGEON DRILLED ALL PROXIMAL SCREWS INCORRECTLY WHEN USING THE T2 PHN TARGETING DEVICE. THE BONDED CONNECTION BETWEEN THE METALLIC AND CARBON PARTS APPEARS TO BE LOOSE. CRACKS ARE VISIBLY PRESENT AT THE JOINT/INTERFACE. 30 MIN SURGICAL DELAY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238066 T2 - TARGETING ARM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH KHI067985 04546540379658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown