BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN¿ SPINAL SYSTEM

    MDR report key: 23578871 · Received November 18, 2025

    Report

    Report Number
    3011795235-2025-00021
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    August 7, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    OVD
    UDI-DI
    00613994676696
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #: 7968812, 510K#: K091813, UDI#: (B)(4) WAS CLEARED IN THE UNITED STATES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(6) INDEX SURGERY (L5-S1 INTERBODY FUSION) IN A PATIENT (PATIENT ID: (B)(6). PATIENT MEDICAL HISTORY: INGUINAL HERNIA IN 1974 AND 1961, APPENDICULAR PERITONITIS, ANTELISTHESIS, OBESITY, PRECORDIALGIA, BACK PAIN AND TYPE 2, GRADE 1 SPONDYLOLISTHESIS. IT WAS REPORTED THAT IN X RAY PERFORMED ON (B)(6) 2025, THERE WAS MOBILIZATION OF THE SACRAL SCREW AND SUSPICION OF DETACHMENT OF THE IMPLANT. HCP REVIEWED THE X RAY ON (B)(6) 2025 IT WAS NOTED THERE WAS MOBILIZATION OF THE SACRAL SCREW IMPLANTED DURING INDEX SURGERY AND AN ANTERIOR ASPECT OF THE CAGE, LEADING TO SUSPECT IMPLANT DISPLACEMENT, WHICH, GIVEN THE SYMPTOMS EXPERIENCED BY THE PATIENT, REQUIRES REOPERATION. PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2025. ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE IMPLANTS. AS PER SITE AND SPONSOR ASSESSMENT, EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783320 SOVEREIGN¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F OVD MSD DEGGENDORF MFG 7969214INT 34LE 00613994676696

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H