BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFACTOR

    MDR report key: 22835021 · Received August 18, 2025

    Report

    Report Number
    3007155473-2025-25284
    Event Type
    Injury
    Date Received
    August 18, 2025
    Report Date
    August 18, 2025
    Manufacturer
    CERAPEDICS INC.
    Product Code
    NOX
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INITIATED AN INVESTIGATION AND ATTEMPTED FOLLOW-UP WITH THE REPORTING HEALTHCARE PROFESSIONALS ON THREE OCCASIONS. NO ADDITIONAL INFORMATION WAS RECEIVED. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED DUE TO LACK OF LOT NUMBER. THE REPORTED FAILURE MODE IS ALREADY ADDRESSED IN THE PRODUCT'S RISK ASSESSMENT AND LISTED IN THE INSTRUCTIONS FOR USE. THE OBSERVED COMPLAINT RATE REMAINS CONSISTENT WITH THE ESTIMATED PROBABILITY FOR THIS FAILURE MODE. NO UPDATES TO LABELING OR RISK DOCUMENTATION ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ON JULY 21, 2025, THE MANUFACTURER RECEIVED A REPORT FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT WHO UNDERWENT AN UNEVENTFUL C3-C4 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) USING IFACTOR PUTTY. POSTOPERATIVELY, THE PATIENT DEVELOPED A CLEAR FLUID COLLECTION OR SEROMA, WHICH REQUIRED URGENT INCISION AND DRAINAGE (I&D). THE REPORTER NOTED THAT THE ANTERIOR DRAIN MAY HAVE BEEN POORLY POSITIONED OR NONFUNCTIONAL. NO ADDITIONAL CLINICAL DETAILS OR PATIENT OUTCOME INFORMATION WERE PROVIDED AT THE TIME OF THE REPORT, NOR WERE THEY AVAILABLE UPON FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865719 IFACTOR PUTTY NOX CERAPEDICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention