BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLASSVAN

    MDR report key: 23222516 · Received October 6, 2025

    Report

    Report Number
    1058382-2025-00003
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 13, 2025
    Manufacturer
    NIRAJ INDUSTRIES PVT. LTD.
    Product Code
    GES
    UDI-DI
    18904233119999
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPDATE: THE FACTORY CONDUCTED AN INVESTIGATION ON RETAIN SAMPLES OF THE SAME PART NUMBER AND LOT NUMBER REPORTED, AND THE SAMPLES MET THE FACTORY'S SPECIFICATIONS FOR DIMENSTIONAL TOLERANCES, AND HANDLE FITMENT. THE SUSPCT DEVICE WAS NOT AVAILABLE FOR EXAMINATION, AS THE END-USER DISCARDED IT AFTER TI WAS REMOVED. A COPY OF THE FACTORY'S REPORT IS INCLUDED WITH THIS UPDATED REPORT. THIS CONCLUDES THE INVESTIGATION AND WE CONSIDER THIS COMPLAINT CLOSED. ON (B)(6) 2025: IT WAS REPORTED THAT DURING THE RIGHT XLIF PROCEDURE A FOREIGN OBJECT WAS NOTED ON X-RAY AFTER TEMPLATING OF INTERBODY CAGE. WAS DETERMINED TO BE A BLADE THAT HAD BEEN EXTRACTED FROM INSTRUMENT AND REMAINED IN L2-3 LEVEL. A DETERMINATION WAS MADE TO REMOVE THE BLADE OBJECT IN DOING A LEFT DIRECT APPROACH PROCEDURE TO REMOVE OBJECT WHICH CREATED A SECONDARY PROCEDURE, AND STAGING OF CASE FOR A LATER DATE. THE OBJECT WAS DETERMINED TO BE A MYCO MEDICAL GLASS VAN CS SURGICAL BLADE. THE REF #(B)(4), LOT #210311MC, EXPIRES: 11-22-2026, MYCO REORDER #(B)(4). MYCO MEDICAL PHONE # (B)(6). THE OBJECT WAS REMOVED AND VERIFIED WITH X-RAY THAT NO OTHER FRAGMENTS WERE INTACT WITHIN LEFT L4-L5 LEVEL OF REMOVING THE OBJECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE RIGHT XLIF PROCEDURE A FOREIGN OBJECT WAS NOTED ON X-RAY AFTER TEMPLATING OF INTERBODY CAGE. WAS DETERMINED TO BE A BLADE THAT HAD BEEN EXTRACTED FROM INSTRUMENT AND REMAINED IN L2-3 LEVEL. A DETERMINATION WAS MADE TO REMOVE THE BLADE OBJECT IN DOING A LEFT DIRECT APPROACH PROCEDURE TO REMOVE OBJECT WHICH CREATED A SECONDARY PROCEDURE, AND STAGING OF CASE FOR A LATER DATE. THE OBJECT WAS DETERMINED TO BE A MYCO MEDICAL GLASS VAN CS SURGICAL BLADE. THE REF #01999, LOT #210311MC, EXPIRES: 11-22-2026, MYCO REORDER #(B)(4). MYCO MEDICAL PHONE # (B)(6). THE OBJECT WAS REMOVED AND VERIFIED WITH X-RAY THAT NO OTHER FRAGMENTS WERE INTACT WITHIN LEFT L4-L5 LEVEL OF REMOVING THE OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263811 GLASSVAN SURGICAL BLADE GES NIRAJ INDUSTRIES PVT. LTD. 210311MC 18904233119999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention