BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURE-C

    MDR report key: 24485165 · Received March 2, 2026

    Report

    Report Number
    3004142400-2026-00052
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 6, 2026
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    QLQ
    PMA / PMN Number
    Q200722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 1417 DURAL TEAR MEDSUN REPORT: (B)(4). THE INCIDENT OCCURRED (B)(6) 2026. IT WAS INITIALLY REPORTED THAT THE BROACH TIPS BROKE OFF IN VERTEBRAL BODY AND WERE ADVANCED BY THE CHISEL. THE TIPS WERE REMOVED FROM THE DURA. DURAL REPAIR WAS PERFORMED AND THE PATIENT HAS NO NEUROLOGICAL DEFICIT. ADDITIONAL INFORMATION WAS REPORTED THAT THE BLADES OF KEEL CUTTER BROKE OFF DURING THE PROCEDURE RESULTING IN DUROTOMY/CSF [CEREBRAL SPINAL FLUID] LEAK WHICH WAS REPAIRED IN THE OPERATING ROOM. THE PATIENT WAS ADMITTED TO ICU POST-OP DUE TO THE CSF LEAK. THE PATIENT WAS DETERMINED TO HAVE NO SPINAL CORD INJURY. BASED ON THE INFORMATION PROVIDED. THE PATIENT DID NOT EXPERIENCE ANY PRECIPITATING EVENTS (E.G., TRAUMA, CAR ACCIDENT). THE SURGERY WAS A REVISION OF A PREVIOUS DISC REPLACEMENT. AN ORTHOFIX M6 DISC WAS REMOVED AND REVISED TO THE GLOBUS SECURE-C IMPLANT. NOTE: THE SAFETY AND EFFECTIVENESS OF SECURE-C HAS NOT BEEN ESTABLISHED IN PATIENTS WITH PRIOR SURGERY AT THE LEVEL TO BE TREATED. THIS IS MENTIONED AS A PRECAUTION IN THE SECURE-C IFU. THE BROACHING CHISEL IS USED TO PREPARE THE SLOTS FOR THE KEELS OF THE SECURE-C ARTIFICIAL CERVICAL DISC. THE PART WAS RETURNED FOR EVALUATION. BOTH TIPS, LOWER AND UPPER, WERE BROKEN OFF BUT NOT INCLUDED. THE REST OF THE PART DOES NOT APPEAR TO BE DAMAGED. THE CORRESPONDING DEVICE HISTORY RECORD HAS BEEN REVIEWED AND CONFIRMS THE LOT MET THE INCOMING INSPECTION, DIMENSIONAL AND MATERIAL SPECIFICATIONS. MEASUREMENTS COULD NOT BE TAKEN ON THE BROKEN TIPS AS THEY WERE NOT RETURNED. NO DETERMINATIONS CAN BE MADE FOR THE CAUSE OF THE REPORTED ISSUE AT THE MOMENT. IT IS POSSIBLE THAT THE DENSITY OF THE BONE WAS HARDER THAN USUAL DUE TO THE PRIOR DISC REPLACEMENT AT THE LEVEL. THE SECURE-C IFU MENTIONS PRIOR SURGERY AT THE LEVEL AS A PRECAUTION. HOWEVER, IT IS UNCLEAR WHETHER EXCESSIVE FORCE WAS USED, WHETHER THE CORRECT TRIAL HEIGHT WAS USED, OR WHAT THE EXACT CAUSE OF THE ISSUE COULD HAVE BEEN. THIS EVALUATION DETERMINED THAT THIS FAILURE WAS WITHIN EXPECTED RISK; THEREFORE, NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT: A3, A6, B4, D4, D9, G3, G6, H2, H3, H6, H10.

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 1417 DURAL TEAR. MEDSUN REPORT: (B)(4). 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 DURING SURGERY THE BROACH TIPS BROKE OFF IN VERTEBRAL BODY AND WERE ADVANCED BY THE CHISEL. THE TIPS WERE REMOVED FROM THE DURA; DURAL REPAIR WAS PERFORMED AND PATIENT HAS NO NEUROLOGICAL DEFICIT. ADDITIONAL INFORMATION WAS REPORTED THAT THE BLADES OF KEEL CUTTER BROKE OFF DURING THE PROCEDURE RESULTING IN DUROTOMY/CSF [CEREBRAL SPINAL FLUID] LEAK WHICH WAS REPAIRED IN THE OPERATING ROOM. THE PATIENT WAS ADMITTED TO ICU POST-OP DUE TO THE CSF LEAK. THE PATIENT WAS DETERMINED TO HAVE NO SPINAL CORD INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE BROACH TIPS BROKE OFF IN VERTEBRAL BODY AND WERE ADVANCED BY THE CHISEL. THE TIPS WERE REMOVED FROM THE DURA; DURAL REPAIR WAS PERFORMED AND PATIENT HAS NO NEUROLOGICAL DEFICIT. ADDITIONAL INFORMATION WAS REPORTED THAT THE BLADES OF KEEL CUTTER BROKE OFF DURING THE PROCEDURE RESULTING IN DUROTOMY/CSF [CEREBRAL SPINAL FLUID] LEAK WHICH WAS REPAIRED IN THE OPERATING ROOM. THE PATIENT WAS ADMITTED TO ICU POST-OP DUE TO THE CSF LEAK. THE PATIENT WAS DETERMINED TO HAVE NO SPINAL CORD INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538937 SECURE-C ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, REUSABLE QLQ GLOBUS MEDICAL, INC. 614.758 VIL223CB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R