BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 20810698 · Received November 29, 2024

    Report

    Report Number
    1030489-2024-01607
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    December 14, 2022
    Report Date
    November 29, 2024
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00613994290922
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF EVENT: CHINA. H3: PRODUCT ANALYSIS # (B)(4): PART # 2991422, LOT # H5466622 VISUAL AND OPTICAL INSPECTION REVEALED THE IMPLANT WAS RETURNED DAMAGED. THE INNER THREADS AND OUTER RIBS HAVE BEEN STRIPPED/DAMAGED. THE IMPLANT IS FRAGILE AND CAN BE OVERLOADED. IT APPEARS THE IMPLANT WAS DAMAGED DURING THE IMPLANTATION AND REMOVAL PROCESS. 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 HAVING OPEN AND DECOMPRESSED REDUCTION AND INTERNAL FIXATION FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SPACER DAMAGED DURING THE SOLERA4.75 SURGERY. THE SPACER BROKE AND THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WERE NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION DONE AS A RESULT OF THIS EVENT. THE CAGE DAMAGED DURING IMPLANTATION AND IT REPLACED DURING THE SAME SURGERY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616570 CAPSTONE® SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 2991422 H5466622 00613994290922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown