BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18886502 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-23131
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    March 21, 2023
    Report Date
    March 11, 2024
    Manufacturer
    CERAPEDICS INC.
    Product Code
    NOX
    UDI-DI
    00850001680028
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR WAS REVIEWED FOR LOT 22C1297 AND INDICATED NO ABNORMAL PROCESSING. THE LOT IN QUESTION MET ALL SPECIFICATIONS PRIOR TO ITS RELEASE. THERE HAVE BEEN NO NCRS OR CAPAS ASSOCIATED WITH THIS LOT. CERAPEDICS RISK ANALYSIS DOCUMENT RA-001, REVISION 23 (PUTTY) WAS REVIEWED. THE FAILURE MODE IDENTIFIED IN THIS COMPLAINT IS ALREADY IDENTIFIED UNDER LINE ITEM 38 (POTENTIAL EFFECT 3) - "INADEQUATE RETENTION IN GRAFT SITE, MIGRATION." THEREFORE, NO UPDATES TO THE RISK ASSESSMENT ARE REQUIRED. THERE HAS BEEN 1 (ONE) PREVIOUS COMPLAINT RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N=(B)(4)), THE OBSERVED RATE IS (B)(4) %. THE MITIGATED RISK PROBABILITY FOR THIS POTENTIAL FAILURE MODE IS ESTIMATED TO BE 1 OR AN ESTIMATED OCCURRENCE RATE OF 0.01%. THEREFORE, THE BENEFIT-RISK ANALYSIS REMAINS UNCHANGED. US PUTTY IFU (P/N 40002-07-4) LISTS THE FOLLOWING: "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 INITIALLY SAW THE PATIENT ON (B)(6) 2023 FOR A SCHEDULED 2-LEVEL ACDF AT C3/C5. NO ADVERSE EVENTS OCCURRED DURING SURGERY AND PATIENT PRESENTED WITH NO COMPLICATIONS IMMEDIATELY POST-OP. THE PATIENT RETURNED TO SURGEON'S OFFICE ON (B)(6) 2023, 5 DAYS POST-OP WITH SIGNIFICANT ANTERIOR AND LEFT TRACHEAL SWELLING WITH TENDERNESS TO PALPATION. THE PATIENT'S DIFFICULTY SWALLOWING RAISED CONCERN AS THE PATIENT WAS UNABLE TO EAT OR DRINK ANYTHING INCLUDING WATER. THE PATIENT WAS SENT DIRECTLY BACK TO DELRAY MEDICAL CENTER EMERGENCY ROOM FOR ADMISSION. CERVICAL A/P AND LATERAL X-RAYS SHOW SIGNIFICANT PRE-VERTEBRAL SWELLING WITH ANTERIOR C2-C7 DISPLACEMENT (27MM) OF THE TRACHEA WITHOUT DISPLACEMENT FROM MIDLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715975 I-FACTOR PUTTY FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX CERAPEDICS INC. 700-050 22C1297 00850001680028

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other