BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 21409104 · Received February 19, 2025

    Report

    Report Number
    1030489-2025-00838
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    November 9, 2022
    Report Date
    February 19, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00613994972866
    PMA / PMN Number
    K113528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN - INDIA H3: PRODUCT ANALYSIS: PART # 2922245; LOT # 12LX VISUAL AND MACROSCOPIC INSPECTION REVEALED THE INNER THREADS OF THE ATTACHMENT AREA HAVE BEEN STRIPPED. THE DAMAGE APPEARS TO BE FROM TORSIONAL OVERLOAD. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 DEVICE USED FOR OLIF PROCEDURE. IT WAS REPORTED THAT THE CAGE DID NOT HAVE AN ENGAGING THREAD WITH THE INSTRUMENT FOR CAGE PLACEMENT. THE PRODUCT DID NOT COME IN CONTACT WITH PATIENT AS THE CAGE WAS NOT LOADING ONTO THE INSERTER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572212 CLYDESDALE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 2922245 12LX 00613994972866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown