BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MICROMATRIX

    MDR report key: 12664980 · Received October 20, 2021

    Report

    Report Number
    3005920706-2021-00003
    Event Type
    Injury
    Date Received
    October 20, 2021
    Report Date
    November 22, 2021
    Manufacturer
    INTEGRA - ACELL(COLUMBIA)
    Product Code
    KGN
    PMA / PMN Number
    K172399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MICROMATRIX WAS NOT RETURNED FOR EVALUATION (RESORBABLE PRODUCT). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER, INDICATED THE DEVICE (A POWDER) WAS HYDRATED OR RECONSTITUTED WITH PRP AND ADIPOSE FAT (STEM CELL) FOR THE DOCTOR TO BE ABLE TO INJECT THE RECONSTITUTED PRODUCT INSIDE THE NASAL CAVITY OF THE PATIENT. THE MICROMATRIX IS NOT INTENDED FOR USE IN EMPTY NOSE SYMPTOM AND SHOULD NOT BE RECONSTITUTED WITH PRP AND ADIPOSE FAT (STEM CELL). AS PRODUCT REFERENCE NO, LOT NUMBER AND SERIAL NUMBER ARE NOT AVAILABLE, A COMPREHENSIVE REVIEW OF MANUFACTURING RECORDS (DHR) WAS NOT POSSIBLE. HOWEVER, EVERY MICROMATRIX LOT IS MANUFACTURED FOLLOWING STRINGENT VALIDATED PROCESSES UNDER CLASS 7 CLEAN ROOM CONDITIONS AND IS STERILIZED TO SAL10-6 USING ELECTRON BEAM IRRADIATION STERILIZATION PROCESS. FURTHERMORE, ALL LOTS OF MICRO MATRIX DEVICES ARE ALSO TESTED FOR ENDOTOXIN THREE TIMES, IMMEDIATELY FOLLOWING DISINFECTION, IN-PROCESS AND FINAL DEVICE LOT RELEASE TESTING (AFTER STERILIZATION). INTEGRA/ ACELL ENDOTOXIN SPECIFICATION IS ESTABLISHED AS PER USP <161>. ANY LOT NOT MEETING THE ENDOTOXIN SPECIFICATION THE ENTIRE LOT IS IMMEDIATELY REJECTED AND SCRAPPED. ROOT CAUSE IS UNDETERMINED. WITH THE INFORMATION PROVIDED BY THE COMPLAINANT THUS FAR, A DEFINITIVE SOURCE OR CAUSE OF INFECTION CANNOT BE ESTABLISHED. MICROMATRIX IS NOT RECOMMENDED TO BE RECONSTITUTED WITH PRP AND ADIPOSE FAT (STEM CELL), AND ALSO IS NOT RECOMMENDED TO BE USED FOR EMPTY NOSE SYMPTOM WHICH IS DEEMED A MODIFICATION TO THE PRODUCT AND AN OFF-LABEL USE. IT IS ALSO UNKNOWN IF THE DOCTOR SHARED THE CONTENT OF ONE VIAL OF MICROMATRIX WITH MORE THAN ONE PATIENT. AS PER IFU, THE DEVICE IS INTENDED FOR ONE-TIME USE. IN ADDITION, IT IS ALSO UNKNOWN HOW THE DEVICE (A POWDER) WAS HYDRATED OR RECONSTITUTED WITH PRP AND ADIPOSE FAT (STEM CELL) FOR THE DOCTOR TO BE ABLE TO INJECT THE RECONSTITUTED MICROMATRIX INSIDE THE NASAL CAVITY OF THE PATIENT. UNKNOWN IF THE RECONSTITUTION PROCESS WAS ASEPTIC.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED INFECTION ON THE FOREHEAD WITH THE USE OF MICROMATRIX INTERNALLY (NASAL CAVITY SEPTUM): A (B)(6) YO CAUCASIAN MALE WITH PREEXISTING CONDITION OF "EMPTY NOSE SYMPTOM", WAS INJECTED WITH ACELL PRP AND ADIPOSE (STEM CELL) INTO NASAL SEPTUM UNDER LOCAL ANESTHESIA ON (B)(6) 2021. LOT OR SERIAL NUMBER IS UNKNOWN. IMMEDIATELY AFTER INJECTION, PATIENT EXPERIENCED MINOR HEADACHE(FRONTAL). ON (B)(6) 2021 PATIENT CONTINUED WITH FRONTAL PAIN WHICH BECAME WORSE AND BUMP ON FOREHEAD AND PATIENT WENT TO PHYSICIAN¿S OFFICE. DR. PRESCRIBED ANTIBIOTIC. PATIENT WAS STILL EXPERIENCING PAIN AND APPROXIMATELY 3 WEEKS AFTER INJECTION OF ACELL, PHYSICIAN PERFORMED URGENT SINUS SURGERY TO DRAIN AND REMOVE INFECTION FROM SEPTUM. NEXT DAY, PATIENT WAS PRESCRIBED METHYLPREDNISOLONE TO REDUCE INFLAMMATION. INFECTION WAS DETERMINED TO BE STAPH. PATIENT WAS TREATED WITH CIPRO (STOPPED USING DUE TO THYROID PROBLEM). AUGMENTIN AND PREDNISONE, WERE OTHER MEDICATIONS ADMINISTERED. PATIENT IS STILL ON LEVOQUIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564982 UNKNOWN MICROMATRIX MICROMATRIX KGN INTEGRA - ACELL(COLUMBIA)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male