BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 19492703 · Received June 7, 2024

    Report

    Report Number
    3007155473-2024-24173
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 6, 2024
    Manufacturer
    CERAPEDICS
    Product Code
    NOX
    UDI-DI
    00850001680004
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 23C1770. ONE NCR IS ASSOCIATED WITH THE FOIL POUCH LOT USED, NCR 986. HOWEVER, THE NCR IS ONLY RELATED TO THE FOIL POUCH AND HAD NO IMPACT ON THE FINISHED PRODUCT. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT 23C1770. CAPAS AND NCRS ASSOCIATED WITH LOT NCR 986 WAS ASSOCIATED WITH THE FOIL POUCH LOT USED. BUBBLES WERE OBSERVED IN THE FOIL POUCH. POUCHES WERE SORTED AFTER STERILIZATION AND IMPACTED POUCHES WERE SEGREGATED FOR QC TESTING OR SCRAP. THIS NCR HAD NO IMPACT ON THE FINISHED PRODUCT. RISK ANALYSIS AND PREVIOUS COMPLAINTS (B)(4) 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 4 (FOUR) 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 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. CONCLUSION BASED ON THE INFORMATION AVAILABLE, A CAUSAL LINK BETWEEN THE PUTTY PRODUCT AND THE SEROMA CANNOT BE ESTABLISHED. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION THIS COMPLAINT IS BEING INCORPORATED INTO THE RISK MANAGEMENT PROCESS. AS LISTED IN THE IFU (P/N 40002-07-4), WOUND COMPLICATION IS LISTED AS A POTENTIAL ADVERSE EFFECT; THEREFORE, NO ADDITIONAL ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    ON THURSDAY, 25 APRIL 2024, EA RECEIVED THE FOLLOWING EMAIL FROM (B)(6), ((B)(6) EMPLOYEE): "EMILY: I TRUST YOU ARE WELL. I RECEIVED A CALL FROM MY DISTRIBUTOR THAT WORKS WITH DR. (B)(6) IN LAKE CHARLES. HE HAS SOME CONCERNS BASED ON RECENT OPERATIVE OUTCOMES "INVOLVING IFACTOR" HE'D LIKE TO DISCUSS THIS WITH SOMEONE TOMORROW AND IS AVAILABLE TOMORROW 10:30 CENTRAL STANDARD TIME. PLEASE LET ME KNOW IF YOU ARE ABLE TO CONNECT WITH HIM SO I CAN MAKE HIM AWARE. THANK YOU IN ADVANCE. CHEERS, (B)(6) REGIONAL SALES MANAGER-SOUTHEAST" EA CALLED DR. (B)(6) ON FRIDAY, 26 APRIL 2024 AS REQUESTED, BUT WAS NOT ABLE TO CONNECT WITH SURGEON. ADDITIONAL INFORMATION RECEIVED ON 13 MAY 2024: ON 13 MAY 2024, EA RECEIVED THE FOLLOWING EMAIL FROM DR. (B)(6) "HI EMILY, 1. PRODUCT INFORMATION: PART NUMBER AND LOT NUMBER / PRODUCT #: 700-010 / LOT #: 23C1770 2. DATE OF EVENT / WEDNESDAY, 04/24/2024 3. DATE OF INITIAL SURGERY / DOS: (B)(6) 2024 4. GLOBUS MEDICAL COLONIAL CAGE, GLOBUS MEDICAL RESONATE PLATE WITH SCREWS 5. PATIENT DEVELOPED SIGNIFICANT PRE VERTEBRAL EDEMA WHICH DYSPHAGIA 6. PATIENT REQUIRED RETURN TO SURGERY FOR WASHOUT OF PRE VERTEBRAL SPACE AND PLACEMENT OF DRAIN. PLEASE CALL ME AT (B)(6) (CELL) IF YOU REQUIRE ADDITIONAL DETAILS. THANKS, ERICH"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310588 I-FACTOR PUTTY FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX CERAPEDICS 700-010 23C1770 00850001680004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other GLOBUS MEDICAL COLONIAL CAGE| GLOBUS MEDICAL RESONATE PLATE WITH SCREWS