BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN (PUTTY OR MATRIX)

    MDR report key: 18889044 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-23147
    Event Type
    Injury
    Date Received
    March 12, 2024
    Report Date
    March 12, 2024
    Manufacturer
    CERAPEDICS INC.
    Product Code
    MBS
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT NUMBER WAS PROVIDED A DHR REVIEW COULD NOT BE COMPLETED. AS NO LOT NUMBER WAS PROVIDED A REVIEW OF CAPAS AND NCRS COULD NOT BE COMPLETED. 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 6 (SIX) PREVIOUS COMPLAINTS RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N= (B)(4)) THE OBSERVED RATE IS 0.002%. THE MITIGATED RISK PROBABILITY FOR THIS POTENTIAL FAILURE MODE IS ESTIMATED TO BE 2 OR AN ESTIMATED OCCURRENCE RATE OF 0.25%. THEREFORE, THE BENEFIT-RISK ANALYSIS REMAINS UNCHANGED. US PUTTY IFU (P/N 40002-07-4) LISTS THE FOLLOWING AS A POTENTIAL ADVERSE EVENT: "WOUND COMPLICATIONS INCLUDING HEMATOMA, SITE DRAINAGE, INFECTION DEHISCENCE AND/OR NECROSIS". AS SUCH, NO UPDATES ARE REQUIRED FOR THE IFU.

    Description of Event or Problem · 0

    IN A CONVERSTATION AT NASS, SURGEON STATED THAT HE HAD A CASE WITH A STERILE SEROMA. IN FOLLOW-UP EMAIL, SURGEON STATED THAT THE PATIENT REQUIRED SURGICAL INTERVENTION TO DRAIN THE SEROMA AND HAS SINCE MADE A GOOD RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717142 UNKNOWN (PUTTY OR MATRIX) FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other