BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIFY HALO

    MDR report key: 25329224 · Received May 29, 2026

    Report

    Report Number
    3015392173-2026-00003
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SURGIFY MEDICAL OY
    Product Code
    HBE
    UDI-DI
    06429811532076
    PMA / PMN Number
    K251433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS IDENTIFIED MULTIPLE CONDITIONS DURING THE PROCEDURE THAT FELL OUTSIDE THE IFU-SPECIFIED PARAMETERS: INTRAOPERATIVE CONTACTS BETWEEN THE DEVICE AND THE METAL SUCTION TUBE, EXCESSIVE FORCE USED, EXCEEDING THE MAXIMUM CONTINUOUS USE TIME, AND INSUFFICIENT IRRIGATION. THESE DEVIATIONS FROM THE IFU ARE CONSIDERED LIKELY CONTRIBUTING FACTORS TO THE REPORTED OUTCOME. 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 CLINICAL STUDY PROCEDURE (OPEN SPINAL SURGERY), A SMALL METAL FRAGMENT DISLODGED FROM THE BURR. THE DEVICE STAYED INTACT OTHERWISE; THE FRAGMENT WAS FULLY RETRIEVED INTRAOPERATIVELY, AND NO PATIENT HARM RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377777 SURGIFY HALO DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE SURGIFY MEDICAL OY 40.000.SEE.H1 10334 06429811532076

    Patients

    Seq Age Sex Outcome Treatment
    1