BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18886929 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-23139
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    July 13, 2023
    Report Date
    March 11, 2024
    Manufacturer
    CERAPEDICS INC.
    Product Code
    MBS
    UDI-DI
    00850001680158
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DESIGN HISTORY RECORD WAS REVIEWED FOR LOT 21C1004 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 (B)(4), 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 9 (NINE) PREVIOUS COMPLAINTS RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N=265,783), 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 (B)(4) THEREFORE, THE BENEFIT-RISK ANALYSIS REMAINS UNCHANGED. OUS PUTTY IFU (P/N 40002-01-10) LISTS THE FOLLOWING AS A POTENTIAL ADVERSE EFFECT: "EXTRUSION OR MIGRATION OF THE BONE VOID FILLER, AS IS POSSIBLE WITH ANY BONE VOID FILLER, RESULTING IN PAIN, NEURAL IMPINGEMENT, PHYSICAL IMPAIRMENT, IRRITATION OR WEAR OF AN ARTICULATING JOINT, OR LOSS OF FUNCTION; ANY OF WHICH MY REQUIRE REVISION SURGERY." AS SUCH, NO UPDATES ARE REQUIRED FOR THE IFU.

    Description of Event or Problem · 0

    I-FACTOR MIGRATED OUT OF CERVICAL CAGE AND SPREAD OVER THE DURA MATER AND LEFT C5 AND C6 FORAMEN. REVISION SURGERY TO REMOVE I-FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385389 I-FACTOR PUTTY FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS INC. 900-010 21C1004 00850001680158
    408816 I-FACTOR PUTTY FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS INC. 900-010 21C1004 00850001680158

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other UNKNOWN CERVICAL CAGE