BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 21556740 · Received March 10, 2025

    Report

    Report Number
    1030489-2025-01260
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 10, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE IN TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. IT WAS REPORTED THAT THE CT SCAN SHOWSA PSEUDOARTHROSIS L5/S1, CAGE SINTERING LWK 5, SWK 1, SCREW LOOSENING S1 BDS, DISTRACTION LOSS 15.2 TO 11.4MM, LORDOSIS LOSS 32 TO 30.8°. PATIENT HAD POST OPERATIVE BACK PAIN. THERE WAS NO ADDITIONAL/REVISION SURGERY PERFORMED OR PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254213 UNKNOWN THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN SCREW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male