BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI-LOK

    MDR report key: 25033628 · Received April 29, 2026

    Report

    Report Number
    3004142400-2026-00086
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 29, 2026
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OUR
    UDI-DI
    00889095184884
    PMA / PMN Number
    K112028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PART, IMAGES, OR LOT NUMBER WERE RETURNED. DHR RECORDS COULD NOT BE EVALUATED. THE EEF INDICATED THERE WERE NO ADVERSE EVENTS TO THE PATIENT. A RISK EVALUATION WAS CONDUCTED (ABOVE), AND IT WAS FOUND THAT THE OBSERVED RISK LEVEL (LOW) IS WITHIN THE EXPECTED RISK LEVEL (MEDIUM). THE REP CONFIRMED THE SURGEON FELT THERE WAS NO DEVICE PROBLEM AND THAT IT WAS BEST TO NOT REOPERATE. THE MIR WORKSHEET HAS BEEN COMPLETED, WITH NO TREND OBSERVED, AND IS ATTACHED. SINCE THE OBSERVED RISK IS WITHIN THE EXPECTED RISK LEVEL, NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. NO FURTHER EVALUATION WAS POSSIBLE. THIS EVALUATION WILL BE REOPENED IF MORE INFORMATION BECOMES AVAILABLE. BASED ON THE EVALUATION AND AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE HAS BEEN AN INQUIRY FROM A SURGEON WHO IMPLANTED SILOK IN 2024 ABOUT REMOVAL. THE PATIENT BELIEVES THAT THE IMPLANT IS CAUSING PAIN AND WANTS THE IMPLANT REMOVED. THE SURGEON BELIEVES THE JOINT IS FUSED AND THAT REMOVAL MAY NOT BE THE BEST COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34002 SI-LOK TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE OUR GLOBUS MEDICAL, INC. 139.503S 00889095184884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other