BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR

    MDR report key: 23659322 · Received November 26, 2025

    Report

    Report Number
    3007155473-2025-25310
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 26, 2025
    Report Date
    November 25, 2025
    Manufacturer
    CERAPEDICS
    Product Code
    NOX
    UDI-DI
    00850001680004
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE US INSTRUCTIONS FOR USE (IFU) FOR PUTTY (40002-07-5) IDENTIFY "SOFT TISSUE DAMAGE OR FLUID COLLECTIONS, INCLUDING HEMATOMA OR SEROMA" ALSO "WOUND COMPLICATIONS INCLUDING HEMATOMA, SITE DRAINAGE, INFECTION, DEHISCENCE, AND/OR NECROSIS" AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ANY SURGICAL PROCEDURE. NO UPDATES TO THE IFU ARE WARRANTED AT THIS TIME. BASED ON THE INVESTIGATION PERFORMED, A CAUSAL LINK BETWEEN I-FACTOR AND THE ADVERSE EVENT CANNOT BE ESTABLISHED. OBSERVED RATES OF WOUND COMPLICATIONS ARE WITHIN EXPECTED LEVELS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SURGEON REPORTED A SEROMA AFTER THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH BREATHING DIFFICULTIES THREE DAYS POST SINGLE-LEVEL ACDF USING THE I-FACTOR PUTTY PRODUCT. THE QUALITY TEAM FOLLOWED UP WITH THE SURGEON FOR MORE DETAILS. THE SURGEON PROVIDED THE SURGERY DATE, HOSPITAL NAME, PRODUCT LOT NUMBER, AND CONFIRMED NO REVISION SURGERY WAS PERFORMED. ADDITIONAL INFORMATION INCLUDED OTHER PRODUCTS USED DURING THE PROCEDURE AND A CLINICAL NARRATIVE DESCRIBING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569952 I-FACTOR PUTTY NOX CERAPEDICS 700-010 25C2341 00850001680004

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R