BEUDAMED
    FDA Adverse Event Death Summary report: N

    SABLE

    MDR report key: 21549849 · Received March 7, 2025

    Report

    Report Number
    3004142400-2025-00069
    Event Type
    Death
    Date Received
    March 7, 2025
    Date of Event
    January 9, 2025
    Report Date
    April 3, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MAX
    UDI-DI
    00889095966022
    PMA / PMN Number
    K192115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IN THE INITIAL SURGERY, THE PATIENT HAD A PRIOR KYPHOPLASTY WITH CEMENT AT T12, WHICH WAS THE SUPERIOR VERTEBRAL BODY OF THE SITE OF INTENDED INTERBODY FUSION. IT IS UNKNOWN WHAT SCREW SYSTEM WAS PRESENT IN THE PATIENT DUE TO THE KYPHOPLASTY. THE INITIAL PROCEDURE WAS ON THURSDAY, (B)(6) 2025. A SABLE SPACER WAS PLACED AT T12-L1 WITH SUPPLEMENTAL FIXATION USING THE REVERE STABILIZATION SYSTEM. IN THE DAYS AFTER SURGERY, THE PATIENT COMPLAINED OF PAIN. A REVISION CASE WAS PERFORMED THE FOLLOWING MONDAY, (B)(6) 2025, TO REMOVE THE IMPLANT. THE IMPLANT WAS REMOVED WITHOUT ISSUE, HOWEVER IN THE FOLLOWING DAYS AFTER SURGERY THE PATIENT PASSED AWAY. IMAGING OF THE SURGICAL SITE WAS PROVIDED. IN THE IMAGING, THE SABLE SPACER APPEARS TO BE IN AN EXPANDED STATE. THE IMPLANT APPEARS TO BE SUBSIDED INTO THE T12 VERTEBRA WITH THE DISTAL TIP OF THE IMPLANT ANGLED CAUDALLY, WITH IMPLANT ENDPLATES NOT PARALLEL TO THE T12 OR L1 VERTEBRAL ENDPLATES. IT APPEARS THAT THE T12 VERTEBRA MAY HAVE FRACTURED, BUT THIS CANNOT BE DEFINITIVELY DETERMINED BASED ON THE PROVIDED IMAGING. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; D6B; G6; H2; H3; H6; H10.

    Description of Event or Problem · 0

    IT WAS REPORTED A WAS SABLE SPACER WAS REMOVED FROM A PATIENT WHO THEN LATER DIED.

    Description of Event or Problem · 0

    IT WAS REPORTED A WAS SABLE SPACER WAS REMOVED FROM A PATIENT WHO THEN LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213062 SABLE SABLE SPACER, 10X26, 9-16MM, 8° MAX GLOBUS MEDICAL, INC. 1172.2113S 00889095966022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death