BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 23592113 · Received November 19, 2025

    Report

    Report Number
    3011795235-2025-00022
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00613994291035
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #708669836, PART # 2990826, LOT# 63PU, A VISUAL REVIEW OF THE RETURNED IMPLANT IDENTIFIED THAT PORTIONS HAVE BEEN BROKEN. MICROSCOPIC EXAMINATION OF THE INSERTER INTERFACE IDENTIFIED DAMAGE TO THE THREADED HOLE AREA AND DEFORMATION ON THE TOP FACE, AND FRACTURE ON ONE SIDE AROUND THE INSERTER TANG INTERFACE, CONSISTENT WITH SIGNIFICANT IMPACT AND TORSIONAL LOADING. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE OF THE BROKEN PORTIONS OF THE IMPLANT IDENTIFIED A FRACTURE WITH RAYS EMANATING AWAY FROM THE AREA OF CRACK INITIATION, CONSISTENT WITH OVERLOAD. THE OBSERVATIONS ARE CONSISTENT WITH IMPACTION OVERLOAD. 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 (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT IMPLANTED WITH SPACER HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR L3-L4 HERNIATED INTERVERTEBRAL DISC AND GRADE 2 SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER TRIALING, THE SURGEON FULLY INSERTED THE CAGE. WHEN ATTEMPTING TO IMPACT THE CAGE FURTHER INTO POSITION, THE SURGEON NOTED THAT THE CAGE HOLDER HAD DETACHED FROM THE CAGE. THE SURGEON REMOVED THE IMPLANT AND ASSOCIATED FRAGMENTS COMPLETELY. A NEW CAGE WAS THEN OPENED, IMPLANTED, AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY, NO PATIENT SYMPTOM WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873538 CAPSTONE® SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 2990826 63PU 00613994291035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male