BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDUCTOS

    MDR report key: 21736685 · Received April 1, 2025

    Report

    Report Number
    1030489-2025-01585
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 1, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    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 510(K)#: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510800, PMA # P000058 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. H6: 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. 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 MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE INVOLVING THE PLACEMENT OF TWO CAGES IN THE L2-L3 AND L3-L4 LEVELS, THE PRODUCT WAS NOT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE INSTRUCTIONS FOR USE/LABELING. THE PROCEDURE WAS RELATED TO A PREVIOUS SURGERY WHERE ARTHRODESE SCREWS AND RODS WERE PLACED FROM L2 TO L5 WITH ONE TRANSVERSE CONNECTION. THE PATIENT WAS NOT ON ANY MEDICATION AT THE TIME OF THE EVENT, AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REPORTED DEVICE SHOULD BE USED FOR 1 LEVEL OF FUSION, BUT THE SURGEON USE IN TWO LEVELS WHICH IS AN OFF LABEL USE. THERE IS NO REVISION SURGERY SCHEDULED OR PLANNED FOR THE REMOVAL OF REPORTED PRODUCT. THERE ARE NO MORE MDT PRODUCTS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954522 INDUCTOS FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P NEK MEDTRONIC SOFAMOR DANEK USA, INC 751090001 4506855274

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female