BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDUCTOS

    MDR report key: 25064650 · Received May 4, 2026

    Report

    Report Number
    1030489-2026-00008
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    UDI-DI
    00643169060104
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PRODUCT IS NOT MARKETED IN THE UNITED STATES BUT A SIMILAR DEVICE WITH PRODUCT NUMBER 7510800 WITH PMA # P000058 AND UDI (B)(4) IS MARKETED IN US. ADDITIONAL CODES: ANNEX G CODE PREFERRED TERM IS RECOMBINANT BONE MORPHOGENETIC PROTEIN. 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 GETTING TREATED FOR THE PRE-OPERATIVE DIAGNOSIS OF NON-FUSION. IT WAS REPORTED THAT THE PRODUCT WAS UTILIZED CORRECTLY BUT ON 2 DIFFERENT LEVELS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PROCEDURE BEING CARRIED OUT DURING THE OCCURRENCE OF THE EVENT WAS REOPERATION AFTER A PSEUDARTHROSIS AT L2 ¿ S1 SPINAL LEVELS. THE PRODUCT WAS IMPLANTED IN THE CAGE PLACED IN L2-L3 LEVEL AND IN THE POSTERIOR JOINTS, L5-S1 LEVEL. PATIENT INVOLVED DID NOT EXPERIENCE ANY COMPLICATIONS AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30895 INDUCTOS FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P NEK MEDTRONIC SOFAMOR DANEK USA, INC. 751090001 4507794679 00643169060104

    Patients

    Seq Age Sex Outcome Treatment
    1