BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFACTOR

    MDR report key: 23183597 · Received September 30, 2025

    Report

    Report Number
    3007155473-2025-25294
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 30, 2025
    Manufacturer
    CERAPEDICS
    Product Code
    NOX
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE US PUTTY IFU PN: 40002-07-5 LISTS THE FOLLOWING POTENTIAL ADVERSE EVENTS THAT MAY OCCUR SPECIFICALLY WITH THE USE OF I-FACTOR PEPTIDE ENHANCED BONE GRAFT: "EXTRUSION OR MIGRATION OF THE I-FACTOR PEPTIDE ENHANCED BONE GRAFT, AS IS POSSIBLE WITH ANY BONE GRAFT, RESULTING IN PAIN, NEURAL IMPINGEMENT, PHYSICAL IMPAIRMENT, OR LOSS OF FUNCTION; ANY OF WHICH MAY REQUIRE REVISION SURGERY." BASED ON THE AVAILABLE DATA, INCLUDING DHR REVIEW, CLINICAL DOCUMENTATION, AND RISK ANALYSIS, THE REPORTED EVENT ALIGNS WITH A KNOWN AND MITIGATED FAILURE MODE. WHILE IFACTOR CANNOT BE CONCLUSIVELY IDENTIFIED AS THE ROOT CAUSE, ITS CONTRIBUTION CANNOT BE RULED OUT. THE COMPLAINT RATE REMAINS WELL BELOW THE ESTIMATED OCCURRENCE RATE, AND NO UPDATES TO THE RISK FILE ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A MULTI-LEVEL CERVICAL SPINE FUSION PROCEDURE USING I-FACTOR PEPTIDE ENHANCED BONE GRAFT. POSTOPERATIVELY, THE PATIENT DEVELOPED ACUTE C5 AND C6 RADICULOPATHIES, PRESENTING WITH PAIN AND SIGNS CONSISTENT WITH NEURAL IMPINGEMENT. IMAGING PROVIDED BY THE SURGEON INDICATED POSSIBLE MIGRATION OF GRAFT MATERIAL FROM THE INTENDED SITE, WHICH MAY HAVE CONTRIBUTED TO NERVE ROOT COMPRESSION. THE OPERATIVE REPORT NOTED MECHANICAL NECK PAIN AND ACUTE RADICULOPATHY. WHILE THE EXACT ROOT CAUSE OF THE ADVERSE EVENT CANNOT BE CONCLUSIVELY ATTRIBUTED TO THE DEVICE, GRAFT MIGRATION IS A KNOWN RISK ASSOCIATED WITH BONE GRAFTING PROCEDURES AND IS LISTED IN THE DEVICE'S INSTRUCTIONS FOR USE (IFU). REVISION SURGERY WAS PERFORMED DUE TO THE SEVERITY OF SYMPTOMS, AND THE PATIENT HAS RECOVERED AND IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106303 IFACTOR PUTTY NOX CERAPEDICS 700-025 24C2207

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H