BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE CONNECT PLATE FIXATION SYSTEM

    MDR report key: 21236270 · Received January 25, 2025

    Report

    Report Number
    1030489-2025-00334
    Event Type
    Malfunction
    Date Received
    January 25, 2025
    Date of Event
    July 5, 2023
    Report Date
    January 25, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THE COUNTRY OF THE EVENT IS JAPAN. G4. PLEASE NOTE THAT THIS DEVICE (G8530207) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE WITH CATALOG# 853-465, 510K# K050082 AND UDI# (B)(4). THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS. H3: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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 PATIENT HAVING C2/5 CERVICAL P OSTERIOR FUSION AND CERVICAL VERTEBRAL ARCH FORMATION FOR AN INDICATION OF OPLL. IT WAS REPORTED THAT THE HINGE BROKE DURING LAMINOPLASTY AFTER FIXATION, SO LAMINOPLASTY WAS NOT PERFORMED. THE EVENT OCCURRED BEFORE IMPLANTING. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404651 CENTERPIECE CONNECT PLATE FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC SOFAMOR DANEK USA, INC G8530207 W790911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown