BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDUCTOS

    MDR report key: 21685619 · Received March 25, 2025

    Report

    Report Number
    1030489-2025-01519
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 25, 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 A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DECORTICATION AND CHANGE OF FEMUR PLATE SPINAL THERAPY FOR FEMUR PSEUDARTHROSIS. IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, A FEMUR PSEUDARTHROSIS WAS BEING TREATED. THE PROCEDURE PERFORMED WAS DECO RTICATION AND CHANGE OF THE FEMUR PLATE. THE PRODUCT WAS USED IN A LONG BONE NON-UNION CONTEXT, AND IT WAS NOTED THAT THE PRODUCT WAS NOT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE INSTRUCTIONS FOR USE/LABELING. THE PATIENT HAD A PREVIOUS SURGERY RELATED TO THIS CONDITION, SPECIFICALLY OSTEOSYNTHESES. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THIS EVENT WAS AN OFF LABEL USE OF DEVICE AND NOT AN USER ERROR. REVISION SURGERY PERFORMED IS NOT DUE TO THE REPORTED PRODUCT. THERE IS NO OTHER REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT INDICATION FOR USE OF BMP2 IS AS A FIRST-LINE TREATMENT IN OPEN FRACTURES OF THE TIBIA BUT IT WAS USED OFF-LABEL FOLLOWING THE PATIENT'S PSEUDARTHROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695246 INDUCTOS FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P NEK MEDTRONIC SOFAMOR DANEK USA, INC 751090001 4506855274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male