BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    MDR report key: 20397690 · Received October 8, 2024

    Report

    Report Number
    1030489-2024-01262
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 11, 2024
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 5030564, 510K # K133653 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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.

    Additional Manufacturer Narrative · 0

    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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) PROCEDURE. IT WAS REPORTED THAT TITANIUM DELAMINATED FROM PEEK POST IMPLANT AND THE CAGE WAS EXPLANTED.THE PATIENT WAS IMPLANTED WITH TWO CORNERSTONES IN (B)(6) 2023. AS A RESULT OF PAIN, SHE WAS OPERATED ON AGAIN ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS FOUND THAT THE TITANIUM COATING OF ONE CORNERSTONE HAD COME LOOSE AND THIS HAD LED TO THE LOOSENING OF THE IMPLANT. OSTEOARTHRITIS HAS FORMED IN THIS CASE. THE TITANIUM COATING MIGRATED TO THE DORSAL AND RESULTED IN PRONOUNCED COMPRESSION OF THE MYELOMA WITH MYELOPATHY, AS WELL AS THE FORMATION OF EXCESS SCAR/GRANULATION TISSUE. PATIENT HAD PAIN AND SENSORY DISTURBANCES, GAIT DISORDERS, SUBSEQUENTLY IMAGING EXAMINATIONS AND REVISION SURGERY. TITANIUMFRAGMENTS DETECTED IN A LABORATORY ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) PROCEDURE. IT WAS REPORTED THAT TITANIUM DELAMINATED FROM PEEK POST IMPLANT AND THE CAGE WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH TWO CORNERSTONES IN (B)(6) 2023. AS A RESULT OF PAIN, SHE WAS OPERATED ON AGAIN ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS FOUND THAT THE TITANIUM COATING OF ONE CORNERSTONE HAD COME LOOSE AND THIS HAD LED TO THE LOOSENING OF THE IMPLANT. OSTEOARTHRITIS HAS FORMED IN THIS CASE. THE TITANIUM COATING MIGRATED TO THE DORSAL AND RESULTED IN PRONOUNCED COMPRESSION OF THE MYELOMA WITH MYELOPATHY, AS WELL AS THE FORMATION OF EXCESS SCAR/GRANULATION TISSUE. PATIENT HAD PAIN AND SENSORY DISTURBANCES, GAIT DISORDERS, SUBSEQUENTLY IMAGING EXAMINATIONS AND REVISION SURGERY. TITANIUM FRAGMENTS DETECTED IN A LABORATORY ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED. 5 NOV 2024, UPDATE RECEIVED ACCORDING TO SURGEON, PATIENT DOES NOT HAVE ANY LONG TERM SYMPTOMS ASSOCIATED WITH CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718066 CORNERSTONE-SR® TI-COATED CAGE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, ODP MSD DEGGENDORF MFG 6221404 98MY

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention