BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18886326 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-23127
    Event Type
    Injury
    Date Received
    March 12, 2024
    Report Date
    March 11, 2024
    Manufacturer
    CERAPEDICS INC
    Product Code
    NOX
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT NUMBER WAS PROVIDED A DHR REVIEW COULD NOT BE COMPLETED. ADDITIONALLY, AS NO LOT NUMBER WAS PROVIDED A REVIEW OF CAPAS AND NCRS COULD NOT BE COMPLETED. CERAPEDICS RISK ANALYSIS DOCUMENT (B)(4), REVISION 23 (PUTTY) WAS REVIEWED. THE FAILURE MODE IDENTIFIED IN THIS COMPLAINT IS ALREADY IDENTIFIED UNDER LINE ITEM 40, - "WOUND COMPLICATIONS INCLUDING HEMATOMA, SITE DRAINAGE, AND INFECTION." THEREFORE, NO UPDATES TO THE RISK ASSESSMENT ARE REQUIRED. THERE HAVE BEEN 0 (ZERO) PREVIOUS COMPLAINTS RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N=265,783), THE OBSERVED RATE IS (B)(4). THE MITIGATED RISK PROBABILITY FOR THIS POTENTIAL FAILURE MODE IS ESTIMATED TO BE 2 OR AN ESTIMATED OCCURRENCE RATE OF (B)(4). THEREFORE, THE BENEFIT-RISK ANALYSIS REMAINS UNCHANGED. US PUTTY IFU (P/N 40002-07-4) LISTS THE FOLLOWING AS A POTENTIAL ADVERSE EFFECT: "WOUND COMPLICATIONS INCLUDING HEMATOMA, SITE DRAINAGE, INFECTION DEHISCENCE AND/OR NECROSIS" AND "SOFT TISSUE DAMAGE OF FLUID COLLECTIONS, INCLUDING HEMATOMA OR SEROMA". ADDITIONALLY, THE IFU STATES: "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."AS SUCH, NO UPDATES ARE REQUIRED FOR THE IFU.

    Description of Event or Problem · 0

    SURGEON STATED THAT AROUND THE 2019 TIME FRAME HE USED I-FACTOR ON 2 PATIENTS IN CERVICAL PROCEDURES. HE STATED THAT IN BOTH PATIENTS A SEROMA FORMED AND IN ONE OF THE PATIENTS A CALCIFIED SHELL OR "CAP" HAD FORMED IN THE TISSUE AWAY FROM THE BONE. THE ACTUAL DATE OF THESE CASES WAS NOT GIVEN. ON MAY 4, 2023 VIA EMAIL SURGEON STATED THAT ONE PATIENT UNDERWENT A REVISION SURGERY FOR THE SEROMA AND TO WASHOUT THE I-FACTOR GRANULES WHICH WERE BEING EXTRUDED THROUGH THE INCISION. HE ALSO STATED THAT HE DOES NOT HAVE ANY ADDITIONAL PRODUCT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029350 I-FACTOR PUTTY FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX CERAPEDICS INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other