BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PUTTY

    MDR report key: 18889195 · Received March 12, 2024

    Report

    Report Number
    3007155473-2024-24162
    Event Type
    Injury
    Date Received
    March 12, 2024
    Report Date
    June 6, 2024
    Manufacturer
    CERAPEDICS INC.
    Product Code
    MBS
    UDI-DI
    00850001680042
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD THE DESIGN HISTORY RECORD WAS REVIEWED FOR LOT 23C1543. THIS IS ONE NCR ASSOCIATED WITH THIS LOT FOR A BROKEN THERMOCOUPLE ON KILN #2. HOWEVER, THIS DID NOT IMPACT THE FINISHED PRODUCT. THE LOT IN QUESTION MET ALL SPECIFICATIONS PRIOR TO ITS RELEASE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR LOT 23C1543. CAPAS AND NCRS ASSOCIATED WITH LOT THIS IS ONE NCR ASSOCIATED WITH THIS LOT FOR A BROKEN THERMOCOUPLE ON KILN #2. HOWEVER, THIS DID NOT IMPACT THE FINISHED PRODUCT. THERE ARE NO CAPAS ASSOCIATED WITH THIS LOT. EXTERNAL MEDICAL CONSULTANT ANALYSIS ON IMAGES AN EXTERNAL MEDICAL CONSULTANT REVIEWED THE PROVIDED IMAGES AND STATED THAT THIS APPEARS TO BE OSTEOLYSIS WITH AN OSTEONECROTIC CLEFT IN THE L4-L5 DISC SPACE. THIS IS OFTEN SEEN WHEN THERE IS A BREACH OF THE ENDPLATE DURING INTERBODY ARTHRODESIS OR THE IMPACTION OF THE CAGE INTO THE DISC SPACE. ADDITIONALLY, THE EXTERNAL MEDICAL CONSULTANT STATED THAT THIS IS NOT SOMETHING THEY HAVE EXPERIENCED WHEN USING I-FACTOR AND STATED THAT THEY DO NOT BELIEVE THAT THE OSTEOLYSIS SEEN IN THE PATIENT IS RELATED TO THE USE OF I-FACTOR. RISK ANALYSIS AND PREVIOUS COMPLAINTS CERAPEDICS RISK ANALYSIS DOCUMENT RA-001, REVISION 23 (PUTTY) WAS REVIEWED. THE FAILURE MODE IDENTIFIED IN THIS COMPLAINT IS ALREADY IDENTIFIED UNDER LINE ITEM 37 - "INADEQUATE BONE REPAIR, INCLUDING NONUNION, MALUNION, DELAYED UNION, LOSS OF REDUCTION, REFRACTURE, OR LACK OF OSSEOUS INGROWTH INTO THE BONE VOID" THEREFORE, NO UPDATES TO THE RISK ASSESSMENT ARE REQUIRED. THERE HAVE BEEN 0 (ZERO) PREVIOUS COMPLAINTS RELATED TO THIS POTENTIAL FAILURE MODE. BASED ON THE TOTAL NUMBER OF UNITS DISTRIBUTED (N=286,101), THE OBSERVED RATE IS 0.0003%. THE MITIGATED RISK PROBABILITY FOR THIS POTENTIAL FAILURE MODE IS ESTIMATED TO BE 2 OR AN ESTIMATED OCCURRENCE RATE OF 0.25%. THEREFORE, THE BENEFIT-RISK ANALYSIS REMAINS UNCHANGED. OUS PUTTY IFU (P/N 40002-01-11) LISTS THE FOLLOWING UNDER POTENTIAL ADVERSE EVENTS: "NONUNION, MALUNION, OR DELAYED UNION" AND "INCOMPLETE OR LACK OF OSSEOUS INGROWTH INTO THE BONE VOID, AS IS POSSIBLE WITH ANY BONE VOID FILLER". AS SUCH, NO UPDATES ARE REQUIRED FOR THE IFU. CONCLUSION BASED ON THE INFORMATION AVAILABLE, NO CAUSAL LINK COULD BE ESTABLISHED BETWEEN I-FACTOR PUTTY AND THE REPORTED COMPLAINT. OTHER POTENTIAL CONTRIBUTING FACTORS TO CONSIDER ARE THE SURGICAL TECHNIQUE USED, THE PATIENT'S PHYSIOLOGY/CONDITION, AND/OR CONCOMITANT DEVICES USED FOR THE SURGERY. NO ADDITIONAL ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING. WILL REVIEW PRODUCTION RECORDS, SIMILAR COMPLAINTS AND CONSULT WITH HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 0

    SURGEON REPORTED TO SPINOTECH THAT ONE OF HIS PATIENT'S BONES APPEAR TO HAVE MELTED AND APPEARED TO BE INFLAMED TO THE INSIDE OF THE SUBCUTANEOUS, AND IT WAS PRESUMED TO BE I-FACTOR. ADDITIONAL INFORMATION: ON 22 MAY 2024, EA RECEIVED THE FOLLOWING EMAIL FROM (B)(6) : "DEAR (B)(6) , AS YOU KNOW, WE PROVIDED THE CONTACT INFORMATION TO (B)(6) PROFESSOR . WHILE WAITING FOR OUR CONTACT, (B)(6) PROFESSOR SHARED AND DISCUSSED THE RESULT WITH OTHER SURGEONS WHO USE THE I-FACTOR. AND HE STARTED USING THE I-FACTOR AGAIN FROM (B)(6) 12TH. I THINK THE REASON WHY HE DOESN'T SEND EMAIL TO (B)(6) DR. IS BECAUSE HE DECIDED TO USE THE I-FATOR AGAIN. I DON'T THINK THERE'S A NEED TO CALL ATTENTION TO (B)(6) PROFESSOR PATIENT CASE AGAIN. PLEASE EXPLAIN THE SITUATION WELL TO B)(6) DR., WHO WOULD HAVE BEEN WAITING FOR (B)(6) PROFESSOR CONTACT. I'M SORRY. BEST REGARDS, (B)(6).

    Description of Event or Problem · 0

    SURGEON REPORTED TO SPINOTECH THAT ONE OF HIS PATIENT'S EXPERIENCED OSTEOLYSIS AND HIS BONES APPEARED TO BE INFLAMED TO THE INSIDE OF THE SUBCUTANEOUS, AND IT WAS PRESUMED TO BE I-FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385536 I-FACTOR PUTTY FILLER, BONE VOID, NON-OSTEOINDUCTION MBS CERAPEDICS INC. 900-025 23C1543 00850001680042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other