BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MATRIX - UNSPECIFIED

    MDR report key: 8214870 · Received January 3, 2019

    Report

    Report Number
    3004170064-2019-00004
    Event Type
    Injury
    Date Received
    January 3, 2019
    Report Date
    December 20, 2018
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K071807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE IS INDETERMINABLE. NO LOT NUMBER WAS PROVIDED IN THE COMPLAINT DOCUMENTATION, THEREFORE DHR REVIEW COULD NOT BE CONDUCTED. THE ONLY INFORMATION PROVIDED WAS THE PRODUCT NAME, SURGIMEND. THE DEVICE WAS NOT RETURNED FOR FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. (B)(4).

    Description of Event or Problem · 1

    PRS GLOBAL OPEN PUBLISHED (2017) "COMPARING THE OUTCOME OF DIFFERENT BIOLOGICALLY DERIVED ACELLULAR DERMAL MATRICES IN IMPLANT-BASED IMMEDIATE BREAST RECONSTRUCTION: A META-ANALYSIS OF THE LITERATURES". THIS STUDY WAS DESIGNED TO STATISTICALLY ANALYZE AND DISCUSS THE OUTCOME OF 3 COMMONLY USED ACELLULAR DERMAL MATRICES (ADMS), ALLODERM (LIFECELL CORP), STRATTICE (LIFECELL CORP), AND SURGIMEND (INTEGRA LIFESCIENCES - TEI - BOSTON)) IN IMPLANT-BASED BREAST RECONSTRUCTION. METHOD: COMPREHENSIVE REVIEW OF THE LITERATURES SEARCHED ON ELECTRONIC DATABASES WAS DONE TO IDENTIFY STUDIES PUBLISHED BETWEEN 2006 AND 2017 COMPARING THE OUTCOME OF ADMS. POOLED RANDOM EFFECT ESTIMATES FOR EACH COMPLICATION AND 95% CONFIDENCE INTERVAL (CI) WERE CALCULATED. COMPLICATIONS NOTICED FOR SURGIMEND 174 / 912 ( SURGIMEND COMPLICATIONS / TOTAL NUMBER OF CASES). MAJOR INFECTION = 32 , EICHLER C ET AL (2015) - 3, GASTER RICHARD S (2013) - 1 , RICCI JA ET AL (2016) - 23 , BALL ET AL (2017) - 5. MINOR INFECTION = 38, EICHLER C ET AL (2015) - 4, EICHLER C ET AL (2017) - 1 , BUTTERFIELD JL (2013) - 17 , RICCI JA ET AL (2016) - 12 , BALL ET AL (2017) - 4. SEROMA = 42, EICHLER C ET AL (2015) - 1, BUTTERFIELD JL ( 2013) - 30 , RICCI JA ET AL (2016) - 7, BALL ET AL (2017) - 4 . HEMATOMA = 11: EICHLER C ET AL (2017) - 1 ; BUTTERFIELD JL (2013) - 4; RICCI JA ET AL (2016) - 5 ; BALL ET AL (2017) - 1 . IMPLANT LOSS = 41: BUTTERFIELD JL (2013) - 29; RICCI JA ET AL (2016) - 10 ; BALL ET AL (2017) - 2 . LOCALIZED INFLAMMATION = 10: EICHLER C ET AL (2015) - 3; EICHLER C ET AL (2017) - 3; BALL ET AL (2017) - 4. RESULTS: TWENTY-ONE STUDIES MET THE INCLUSION WITH A TOTAL OF 1,659, 999, AND 912 BREASTS RECONSTRUCTIONS IN ALLODERM, STRATTICE, AND SURGIMEND, RESPECTIVELY. SEVEN COMPLICATIONS EXTRACTED INCLUDING MAJOR AND MINOR INFECTION, SEROMA, IMPLANT LOSS, HEMATOMA, CAPSULAR CONTRACTURE, AND LOCALIZED ERYTHEMA. POOLED TOTAL COMPLICATION RATES WERE 23.82% IN STRATTICE, 17.98% IN SURGIMEND, 16.21% IN ALLODERM. SEROMA RATE WAS THE HIGHEST IN STRATTICE GROUP (8.61%). THERE WAS NO STATISTICAL SIGNIFICANCE BETWEEN AND WITHIN GROUPS. CONCLUSION: ALTHOUGH STRATTICE EXHIBITED A HIGHER OVERALL POOLED COMPLICATION RATE COMPARED WITH ALLODERM AND SURGIMEND, THE INCIDENCE OF INDIVIDUAL COMPLICATION VARIES BETWEEN STUDIES. A COST ANALYSIS OF DIFFERENT ADMS MAY AID IN CHOOSING THE TYPE OF ADMS TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6824 SURGIMEND MATRIX - UNSPECIFIED N/A FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1