BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPORE SURGICAL IMPLANT

    MDR report key: 12953937 · Received December 7, 2021

    Report

    Report Number
    3009383407-2021-00004
    Event Type
    Injury
    Date Received
    December 7, 2021
    Report Date
    December 7, 2021
    Manufacturer
    MATRIX SURGICAL USA
    Product Code
    FZD
    PMA / PMN Number
    K123908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON REPORTED TO MATRIX SURGICAL USA ON (B)(6) 2021 THAT A (B)(6) YEAR OLD BOY EXPERIENCED AN IMPLANT EXPOSURE. MATRIX SURGICAL USA QUALITY ASSURANCE SUBMITTED AN EMAIL TO DR. (B)(6) ON (B)(6) AND A FOLLOW-UP EMAIL ON (B)(6) TO ASK THE FOLLOWING QUESTIONS TO OBTAIN ADDITIONAL INFORMATION: WHAT WAS THE PRODUCT NUMBER AND LOT NUMBER OF THE IMPLANT?, WHEN DID THE INITIAL IMPLANTATION SURGERY OCCUR?, WERE ANY DEFICIENCIES WITH THE IMPLANT IDENTIFIED PRIOR TO SURGERY?, WHEN DID THE IMPLANT EXPOSURE OCCUR?, WERE ALL POSTOPERATIVE INSTRUCTIONS FOLLOWED?, DID ANY POSTOPERATIVE TRAUMA OCCUR TO THE IMPLANT AREA?, AND WHEN IS THE EXPECTED DATE OF IMPLANT REMOVAL?. DR. (B)(6) RESPONDED ON (B)(6) WITH THE FOLLOWING INFORMATION: NO IMPLANT FAILURE WAS IDENTIFIED, THERE WERE NO IDENTIFIED DEFICIENCIES WITH THE IMPLANT PRIOR TO SURGERY, IT IS UNKNOWN IF POSTOPERATIVE INSTRUCTIONS WERE FOLLOWED, IT IS UNKNOWN IF POSTOPERATIVE TRAUMA OCCURRED TO THE IMPLANT AREA (THE PATIENT IS (B)(6) YRS. OLD), AND THAT SURGICAL INTERVENTION OCCURRED AND SHOWED AN INTACT IMPLANT WITH NO SIGNS OF INFECTION AND CLOSED SOFT TISSUE. A REVIEW OF THE RISK ANALYSIS WAS PERFORMED. THE HAZARD TRACEABILITY MATRIX INCLUDES THE RISK OF THE PATIENT'S BODY NOT ACCEPTING THE IMPLANT. PROCESSES ARE IN PLACE TO ENSURE BIOCOMPATIBILITY OF THE RAW MATERIAL USED ALONG WITH THE REFERENCE OF A LONG HISTORY OF LITERATURE ENSURING THE BIOCOMPATIBILITY OF THE MATERIAL. THE PART NUMBER AND LOT NUMBER OF THE DEVICE IS UNKNOWN DUE TO THE LACK OF INFORMATION PROVIDED BY THE COMPLAINANT; THEREFORE, AN INVESTIGATION OF THE DEVICE WAS UNABLE TO BE PERFORMED. RESULTS OF THE INTERVIEW WITH THE COMPLAINANT (EMAILS) SHOWS THAT THERE WERE NO DEFICIENCIES WITH THE DEVICE, NO FAILURES OF THE DEVICE OCCURRED, THAT IT IS UNKNOWN IF POSTOPERATIVE INSTRUCTIONS WERE FOLLOWED OR IF POSTOPERATIVE TRAUMA OCCURRED TO THE IMPLANT AREA, AND THAT THE TISSUE THAT WAS OPEN, EXPOSING THE IMPLANT, HAS SINCE BEEN CLOSED. IN THE INITIAL NOTIFICATION OF THE EVENT, THE COMPLAINANT STATED THAT THE EXPOSURE WAS PROBABLY CAUSED BY THE POSTOPERATIVE MOLD. THE ADVERSE EVENT THAT OCCURRED WAS NOT ALLEGED TO BE CAUSED BY THE IMPLANT. DUE TO THE LACK OF INFORMATION AVAILABLE AND NO INDICATIONS OF DEVICE DEFICIENCIES, A ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    DR. (B)(6), UNIVERSITY OF (B)(6) DIRECTOR OF CRANIOFACIAL AND PEDIATRIC SURGERY, SUBMITTED AN EMAIL TO (B)(6), MATRIX SURGICAL USA CEO, ON (B)(6) 2021 AND STATED, "THE BOY ABOVE HAS AN EXPOSURE AFTER RETURNING TO KUWAIT AND LIKELY WILL NEED AN IMPLANT EXCHANGE. IT WAS PROBABLY CAUSED BY THE POSTOPERATIVE MOLD ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843949 OMNIPORE SURGICAL IMPLANT EAR IMPLANT FZD MATRIX SURGICAL USA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Hospitalization| R