BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI-LOK

    MDR report key: 23407580 · Received October 28, 2025

    Report

    Report Number
    3004142400-2025-00263
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    July 24, 2025
    Report Date
    November 20, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    LXH
    UDI-DI
    00889095150568
    PMA / PMN Number
    D154976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PART WAS NOT RETURNED FOR EVALUATION. 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 (LOW). THE REP WAS CONTACTED FOR ADDITIONAL INFORMATION AND CONFIRMED THAT THE SURGEON BENT THE RELEVANT K-WIRE BEFORE THE CASE. THIS ACTION MAY HAVE INFLUENCED THE NOTED COMPLAINT. 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, NO CAUSE CAN BE ESTABLISHED. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT. B4, G6, H2, H6, H10.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WIRE WAS CALLED FOR BY SURGEON FOR PELVIC CASE; BENT WIRE PRIOR TO INSERTING. THE WIRE WAS SENT IN AND AS A CANNULATED DRILL WENT OVER IT FOR PRE DRILLING, WIRE BROKE. ABOUT 50-70MM OF WIRE WAS UNABLE TO BE REMOVED FROM PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WIRE WAS CALLED FOR BY SURGEON FOR PELVIC CASE; BENT WIRE PRIOR TO INSERTING. THE WIRE WAS SENT IN AND AS A CANNULATED DRILL WENT OVER IT FOR PRE DRILLING, WIRE BROKE. ABOUT 50-70MM OF WIRE WAS UNABLE TO BE REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254491 SI-LOK SURGICAL DRILL GUIDE, REUSABLE LXH GLOBUS MEDICAL, INC. 639.008 00889095150568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other