BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE¿ PLATE FIXATION SYSTEM

    MDR report key: 19162589 · Received April 23, 2024

    Report

    Report Number
    1030489-2024-00317
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 23, 2024
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A SIMILAR DEVICE CATALOG #853-465, 510K #K050082 AND UDI #(B)(4) IS MARKETED IN THE UNITED STATES. D6A. IMPLANT DATE IS UNKNOWN. 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 A DISTRIBUTOR, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. REMOVAL WAS SCHEDULED IT WAS REPORTED THAT THE ONE SCREW HAD BEEN PLACED DEVIATED INTO THE SPINAL CANAL, SO IT WAS REMOVED. IT WAS REMOVED AND A LAMINECTOMY WAS PERFORMED ON APRIL 3, AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947770 CENTERPIECE¿ PLATE FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS G9010000275 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention