BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18886185 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-22120
    Event Type
    Injury
    Date Received
    March 12, 2024
    Report Date
    March 11, 2024
    Manufacturer
    CERAPEDICS INC
    Product Code
    NOX
    UDI-DI
    0085001680028
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR WAS REVIEWED FOR LOT 21C1149 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 2) - "INADEQUATE RETENTION IN GRAFT SITE, MIGRATION." THEREFORE, NO UPDATES TO THE RISK ASSESSMENT ARE REQUIRED. THERE HAVE BEEN 8 (EIGHT) PREVIOUS COMPLAINTS RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N=265,783), THE OBSERVED RATE IS 0.003%. 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 AS A POTENTIAL ADVERSE EFFECT: "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

    TLIF CAGE SUBSIDED AND GRAFT MATERIAL MIGRATED INTO THE SPINAL CANAL. PATIENT DEVELOPED CAUDA EQUINA SYNDROME. PATIENT REQUIRED DECOMPRESSION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909716 I-FACTOR PUTTY FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX CERAPEDICS INC 700-050 21C1149 0085001680028

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Other GRAFTON DBF, AUTOGRAPH AND TLIF CAGE| PATIENT REQUIRED DECOMPRESSION SURGERY.