BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMATRIX FENESTRATED 4 X 4CM

    MDR report key: 16742368 · Received April 14, 2023

    Report

    Report Number
    3004170064-2023-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Report Date
    June 9, 2023
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    KGN
    PMA / PMN Number
    K153690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE PRIMATRIX (ID (B)(4)) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED AT THE CANADIAN DC TO INVESTIGATE THIS EVENT TO DETERMINE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    A FACILITY REPORTED AN EXPIRED PRIMATRIX PRODUCT WAS PLACED IN A PATIENT: "ITEM# 607-004-440 LOT# 2003035 WITH EXPIRY DATE: MARCH 31,2025 WAS SENT TO AN INTEGRA CANADA REP WITHOUT PROPER "SAMPLE" IDENTIFICATION. REP RECEIVED NO-CHARGE PO TO BRING REQUESTED ITEM# ON SITE TO THE FACILITY ON AHS PO# (B)(4). ON (B)(6). TISSUE WAS MISTAKEN AS ITEM# 607-004-440 LOT# 2003035 ALLOCATED FOR CUSTOMER USE BUT INSTEAD PROVIDED ITEM# 607-004-440 LOT# 2003035 WHICH WAS PREVIOUSLY ALLOCATED FOR SAMPLE USE. TISSUE IN QUESTION THAT WAS PROVIDED TO THE FACILITY WAS STORED AT PROPER TEMPERATURE AND MET ALL SURGICAL AND STERILE AHS REQUIREMENTS AS PACKAGING WAS UNDAMAGED AND HAD NEVER BEEN OPENED. CONDITION OF PACKAGING CAN BE CONFIRMED BY PICTURES TAKEN ON (B)(6)." REASON FOR PRIMATRIX PLACEMENT/SIN LOCATION: ORAL/FACIAL DEFECT RECONSTRUCTION. PLACEMENT DATE: (B)(6) 2023. DID THE PATIENT PRESENTED WITH ANY SIGNS AND SYMPTOMS RELATED TO PRIMATRIX? IF YES, PLEASE PROVIDE DETAILS: DR. HAS NOT INDICATED THERE WERE ANY ADVERSE REACTIONS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306296 PRIMATRIX FENESTRATED 4 X 4CM PRIMATRIX KGN TEI BIOSCIENCES INC 2003035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown