BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA BOVINE PERICARDIUM

    MDR report key: 4846833 · Received June 12, 2015

    Report

    Report Number
    3002924436-2015-00005
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    April 21, 2015
    Report Date
    June 12, 2015
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: GRAFT WAS NOT RETURNED TO RTI FOR EVAL, THEREFORE A RE-REVIEW WAS PERFORMED OF THE MFG RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUAL CONTROL / ASSURANCE REVIEWS AND RELEASE, AND THE COMPLAINT DATABASE FOR RELATED COMPLAINTS ASSOCIATED WITH THE LOT. RESULTS: NO DEVIATIONS WERE NOTED DURING PROCESSING FOR LOT NZ13490047. THE GRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING FOR LOT NZ13490047 WERE ACCEPTABLE. TO DATE, RTI HAS DISTRIBUTED (B)(4) XENOGRAFTS FROM THE LOT WITHOUT RELATED COMPLAINTS. CONCLUSION: THE DEICE WAS NOT RETURNED FOR EVAL. RECORDS RE-REVIEW RESULTS DEMONSTRATED NO DEVIATIONS DURING THE MFG OF GRAFT ID (B)(4) AND IT MET ALL SPEC REQUIREMENTS AND RELEASE CRITERIA AT THE TIME OF DISTRIBUTION. BASED ON OUR RECORDS RE-REVIEW AND THE INFO PROVIDED, THIS EVENT IS UNLIKELY RELATED TO THE XENOGRAFT IMPLANT.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL (B)(4), A WHOLLY OWNED SUBSIDIARY OF RTI, REC'D A COMPLAINT ON 05/13/2015 REPORTING THAT THE SURGEON HAD AN INTRAOPERATIVE CHALLENGE WITH THE BOVINE PERICARDIUM SHOWING WEAK SPOTS ONCE THE SURGEON SUTURED DOWN ALL SIDES OF THE IMPLANT. THE IMPLANT WAS LEFT IN PLACE AND THE SURGEON ADDED DURA SEAL. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383655 INTEGRA BOVINE PERICARDIUM FTM TUTOGEN MEDICAL GMBH NZ13490047

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention