BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18886096 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-22118
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    June 13, 2023
    Report Date
    March 11, 2024
    Manufacturer
    CERAPEDICS INC.
    Product Code
    MBS
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT NUMBER WAS PROVIDED A DHR REVIEW COULD NOT BE COMPLETED. ADDITIOANLLY, AS NO LOT NUMBER WAS PROVIDED A REVIEW OF CAPAS AND NCRS COULD NOT BE COMPLETED. FOLLOWING THE REVISION SURGERY ON (B)(6) 2023, TISSUE SPECIMENS WERE SENT TO HISTOLOGY TO BE FURTHER EXAMINED. IN THE SPECIMEN, EXTRUDED COMMERCIAL BONE GRAFT WAS OBSERVED. MICROSCOPICALLY, SPECIMENS SHOW LACUNAE FILLED WITH SYNTHETIC BONE-LIKE MATERIAL MIMICKING CALCIUM PHOSPHATE DEPOSITS. THESE LACUNAE ARE BOUNDED BY MATURE SKELETAL MUSCLE BUNDLES. SCAR TISSUE AND FAT NECROSIS ARE NOTED. NO ACUTE INFLAMMATION WAS SEEN. NO ATYPIA OR MALIGNANCY WAS SEEN. 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 7 (SEVEN) PREVIOUS COMPLAINTS RELATED TO THIS 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 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.

    Description of Event or Problem · 0

    PATIENT WAS INITIALLY OPERATED UPON IN (B)(6) 2021. SURGERY WAS A SINGLE LEVEL LATERAL INTERBODY PROCEDURE IN WHICH I-FACTOR PUTTY WAS INSERTED INTO STRYKER LATERAL ACCESS AND CASCADIA CAGE K2M. TWO WEEKS POST-SURGERY, THE PATIENT EXPERIENCED LEG AND THIGH PAIN WHICH WAS CONSISTENT WITH SI JOINT ISSUES. NO RELIEF WITH NERVE BLOCKS AND CONTINUED ISSUES / PAIN ON LEG RAISE. INITIALLY REPORTED TO CERAPEDICS ON 8 JUL 2022. ON MAY 3, 2023 QUALITY WAS MADE AWARE THAT THE SURGEON WOULD MOVE FORWARD WITH A REVISION SURGERY FOR HIS PATIENT. ON (B)(6), 2023, REVISION SURGERY OCCURRED. SURGERY WAS EXPLORATORY IN NATURE TO FURTHER EVALUATE OBSERVED MIGRATION. HISTOLOGY WAS REQUESTED TO EVALUATE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221422 I-FACTOR PUTTY FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS INC. 900-050 UNKNOWN
    408815 I-FACTOR PUTTY FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS INC. 900-050 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other STRYKER LATERAL ACCESS AND CASCADIA CAGE K2M.