BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX

    MDR report key: 6870100 · Received September 15, 2017

    Report

    Report Number
    3002719998-2017-00023
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    January 22, 2016
    Report Date
    October 26, 2017
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED TO DATE INDICATED THAT THE XENOGRAFT REMAINS IMPLANTED AND NOT AVAILABLE FOR EVALUATION. THEREFORE, A COMPREHENSIVE RE-REVIEW WILL BE CONDUCTED OF THE MANUFACTURING RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUALITY CONTROL / ASSURANCE REVIEWS AND RELEASE, AND THE COMPLAINT DATABASE FOR RELATED COMPLAINTS, ONCE THE UNIQUE IDENTIFIERS ARE PROVIDED TO RTI.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT IS NOT ASSOCIATED WITH A GRAFT MANUFACTURED BY RTI SURGICAL, INC.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) RECEIVED A COMPLAINT NOTIFICATION ON 08/22/2017 INDICATING THAT A PATIENT UNDERWENT IMPLANTATION OF A FORTIVA PORCINE DERMIS ON AN UNKNOWN DATE, AS PART OF A HERNIA REPAIR CLINICAL STUDY. ON (B)(6) 2016, THE PATIENT DEVELOPED A SEROMA (UNKNOWN SPECIFIC LOCATION). ADDITIONAL INFORMATION HAS BEEN REQUESTED. TO DATE, RTI HAS NOT RECEIVED ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    RTI SURGICAL, INC RECEIVED ADDITIONAL INFORMATION ON 10/11/17 INDICATING THAT THE ALLOGRAFT IMPLANTED IN THIS PATIENT WAS NOT A FORTIVA PORCINE DERMIS. THE GRAFT IMPLANTED WAS A STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX . THE REPORTED COMPLICATIONS WERE ASSOCIATED WITH THE IMPLANTED WITH THE IMPLANTED STRATTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650725 STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX PROCINE DERMIS FTM TUTOGEN MEDICAL GMBH NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other