BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA PORCINE DERMIS

    MDR report key: 11720519 · Received April 23, 2021

    Report

    Report Number
    3002924436-2021-00010
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    August 6, 2020
    Report Date
    October 12, 2021
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH DOCUMENTATION INCLUDING THE ENDOTOXIN TEST, THE INDIVIDUAL DONOR PROTOCOL, THE IKZ PROTOCOL, THE RANDOM SAMPLE TEST AND THE STERILIZATION CERTIFICATE WERE CHECKED. A DISCREPANCY WAS FOUND WHICH, HOWEVER, HAD NO EFFECT ON THE ABOVE PRODUCT. ACCORDING TO THE DOCUMENTATION, THE PRODUCT WAS THEREFORE MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATION. DURING THE TREND ANALYSIS, EIGHT COMPARABLE COMPLAINTS WITH NINE PRODUCTS WERE FOUND FOR ITEM NUMBER 61212, POOL NUMBER PD18100001 AND BATCH T00110. SINCE THIS IS NOT A SPONTANEOUS REPORT, BUT AN INCREASE IN FREQUENCY DUE TO THE CLINICAL STUDY, THERE IS NO TREND. THE CAUSE ANALYSIS WAS CARRIED OUT BY THE SB ON FB-193-24. BASED ON THE DATA RECEIVED AND THE INSPECTION OF THE BATCH DOCUMENTATION, THERE IS NO INDICATION OF THE UNSTERILITY OF THE AFFECTED PRODUCTS. THE NOTIFICATION IS RATED AS NOT ASSOCIATED WITH THE IMPLANTED DEVICE. THE COMPLAINT IS THEREFORE CLASSIFIED AS NOT JUSTIFIED. ACCORDING TO RTI GERMANY'S RECORDS RE-REVIEW SERIAL ID (B)(4) MET SPECIFICATION SP-61100 "04"; ANNEX 1-3 "06"; ANNEX 1-6 "02".

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIERS WERE NOT PROVIDED IN ORDER TO CONDUCT A COMPREHENSIVE RECORDS RE-REVIEW. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI, RECEIVED A COMPLAINT AS PART OF THE (B)(6) TRIAL. THE REPORTED COMPLAINT INDICATED THAT A PATIENT WAS IMPLANTED WITH A FORTIVA PORCINE DERMIS ON AN UNKNOWN DATE. ON (B)(6) 2020, THE PATIENT DEVELOPED A SEROMA. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614944 FORTIVA PORCINE DERMIS SURIGCAL MESH FTM TUTOGEN MEDICAL GMBH PD18100001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other