BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND MATRIX - UNSPECIFIED

    MDR report key: 17510249 · Received August 11, 2023

    Report

    Report Number
    3004170064-2023-00022
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    January 15, 2021
    Report Date
    October 6, 2023
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. SURGIMEND 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 VOLUNTARY RECALL WAS INITIATED FOR ALL PRODUCTS MADE THE INTEGRA BOSTON MANUFACTURING SITE DUE TO POTENTIALLY HIGH LEVELS OF ENDOTOXIN IN THE PRODUCTS. HOWEVER, ENDOTOXIN CONTAMINATION IS LINKED TO FEVER WHICH THE PATIENT DID NOT REPORTEDLY EXPERIENCE IN THIS EVENT.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    STUDY: SURGIMEND ROTATED CAUSING LATERAL CREASING. RE-OPERATION WAS REQUIRED FOLLOWING POST OPERATION COMPLICATION, PROCEDURE RELATED. PATIENT RECOVERED (B)(6), 2023. INVESTIGATOR ACCESSED THE EVENT AS ADVERSE EVENT NOT RELATED TO DEVICE; DEFINITELY RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868200 SURGIMEND MATRIX - UNSPECIFIED N/A FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female