BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIFY HALO

    MDR report key: 25043205 · Received April 30, 2026

    Report

    Report Number
    3015392173-2016-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 30, 2026
    Manufacturer
    SURGIFY MEDICAL OY
    Product Code
    HBE
    UDI-DI
    06429811532250
    PMA / PMN Number
    K253627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT SURGIFY MEDICAL OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT. IF ANY FURTHER INFORMATION BECOMES KNOWN THAT COULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    DURING A BIPORTAL SPINE ENDOSCOPY THE BURR BROKE/DISASSEMBLED. THE EXACT CUTTING TIME WAS NOT TIMED, BUT ACCORDING TO THE INITIAL REPORTER, IT DID NOT EXCEED 5 MINUTES. THE BURR DID NOT COME INTO CONTACT WITH METAL. CONTINUOUS SALINE IRRIGATION WAS MAINTAINED THROUGHOUT THE PROCEDURE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98193 SURGIFY HALO BURR, SURGICAL HBE SURGIFY MEDICAL OY 40.000.SEE.H1 10229 06429811532250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown