BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDUCTOS

    MDR report key: 22881843 · Received August 25, 2025

    Report

    Report Number
    3003120897-2025-00117
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 22, 2025
    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

    A2, A4: ADDITIONAL INFORMATION RECEIVED B5: ADDITIONAL INFORMATION RECEIVED. 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.

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN IS FRANCE. G4: 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.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION RECEIVED. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT PREOPERATIVELY, IT IS A PSEUDARTHROSIS OF THE SHOULDER, THAT IS THE REASON WHY THE SURGEON REALIZE A NEW SURGERY WITH BPM. HOME TREATMENT INCLUDES: BISOPROLOL 5MG 1-0-1; EPLERENONE 50MG 1-0-0; DAPAGLIFLOZIN 10MG 1-0-0; SACUBITRIL/VASLSARTAN (ENTRESTO) 97/103MG 1-0-1. PATIENT ALSO HAD ANTIBIOTIC THERAPY WITH DOXYCYCLINE 200MG/DAY AND CLINDAMYCIN 900MG 3X/DAY WHEN HE WAS DISCHARGED FROM HOSPITAL FOR A PERIOD OF 1 MONTH.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT A NONUNION (PSEUDARTHROSIS) OF THE SHOULDER WAS IDENTIFIED, AND THEPATIENT WAS SUBSEQUENTLY TREATED WITH ARTHRODESIS (FUSION SURGERY) USING INDUCTOS TO ACHIEVE FUSION. THE PROCEDURE WAS PERFORMED PRE-OPERATIVELY FOR A DIAGNOSIS OF SHOULDER PSEUDARTHROSIS. THE SURGEON DECIDED TO PERFORM A NEW SURGERY WITH INDUCTOS AFTER NOTICING THE NONUNION. THERE WERE NO PATIENT COMPLICATIONS/SYMPTOMS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INDUCTOS WAS NOT USED PREVIOUSLY. THIS IS THE FIRST TIME THAT THE PRODUCT WAS USED FOR THE FUSION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT HER CHRONIC TREATMENT (BISOPROLOL 5MG 1-0-1; EPLERENONE 50MG 1-0-0; DAPAGLIFLOZIN 10MG 1-0-0; SACUBITRIL/VALSARTAN (ENTRESTO) 97/103MG 1-0-1 ) WAS TAKEN BEFORE HOSPITALIZATION, AND POST-OPERATIVELY. REGARDING THE ANTIBIOTICS, IT WAS POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291583 INDUCTOS FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P NEK MEDTRONIC SOFAMOR DANEK USA, INC. 751090001 4507229455 00643169060104

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown