BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18886761 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-24160
    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 Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD: THE DESIGN HISTORY RECORD WAS REVIEWED FOR LOT 23C1551 AND INDICATED NO ABNORMAL PROCESSING. THE LOT IN QUESTION MET ALL SPECIFICATIONS PRIOR TO ITS RELEASE. ASIDE FROM THE ASSOCIATED COMPLAINT FROM DR. SEBASTIAN (C24-163), NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR LOT 23C1551. CAPAS AND NCRS ASSOCIATED WITH LOT. THERE HAVE BEEN NO NCRS OR CAPAS ASSOCIATED WITH THIS LOT. RISK ANALYSIS AND PREVIOUS COMPLAINTS: CERAPEDICS RISK ANALYSIS DOCUMENT RA-001, 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 2 (TWO) PREVIOUS COMPLAINTS RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N=286,101), 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 UNDER POTENTIAL ADVERSE EVENTS: "WOUND COMPLICATIONS INCLUDING HEMATOMA, SITE DRAINAGE, INFECTION, DEHISCENCE AND/PR NECROSIS". AS SUCH, NO UPDATES ARE REQUIRED FOR THE IFU. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, NO CAUSAL LINK COULD BE ESTABLISHED BETWEEN I-FACTOR PUTTY AND THE REPORTED COMPLAINT. OTHER POTENTIAL CONTRIBUTING FACTORS TO CONSIDER ARE THE PATIENT'S PHYSIOLOGY/CONDITION, AND/OR CONCOMITANT DEVICES USED FOR THE SURGERY. THE IFU CLEARLY LISTS WOUND COMPLICATIONS AS A POTENTIAL ADVERSE EVENT; THEREFORE, NO ADDITIONAL ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION ONGOING. WILL REVIEW MANUFACTURING RECORDS, SIMILAR COMPLAINTS, IFU AND RISK ANAYLSIS.

    Description of Event or Problem · 0

    SURGEON STATED THAT HE HAS HAD A COUPLE COMPRESSIVE SEROMAS ON CONSECUTIVE POSTERIOR LATERAL PATIENTS. WHEN OPENING THE WOUND IFACTOR WAS FOUND. THIS CONCERNED HIM. REQUIRED RETURN TO THE OR. REPORT FOR 1 OF 2 SURGERIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715990 I-FACTOR PUTTY FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX CERAPEDICS INC. 700-050 23C1551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other