BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOMESH BOVINEPERICARDIUM

    MDR report key: 4823667 · Received June 4, 2015

    Report

    Report Number
    3002924436-2015-00004
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    March 4, 2015
    Report Date
    May 5, 2015
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: GRAFT WAS NOT RETURNED TO RTI FOR EVALUATION, THEREFORE A RE-REVIEW WAS PERFORMED OF THE MANUFACTURING RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUALITY CONTROL/ASSURANCE REVIEWS ADN RELEASE, AND THE COMPLAINT DATABASE FOR RELATED COMPLAINTS ASSOCIATED WITH THE LOT. RESULTS: NO DEVIATIONS WERE NOTED DURING PROCESSING FOR LOT# NZ217160410. THE GRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. TO DATE, RTI HAS DISTRIBUTED 1 XENOGRAFT FROM THE LOT. THERE IS 1 RELATED COMPLAINT ASSOCIATED WITH THE PHYSICIAN, THIS SURGERY TYPE, BUT NOT THE SAME LOT. ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING FOR LOT # NZ217160410 WERE ACCEPTABLE. CONCLUSION: GIVEN THAT NO DEVIATIONS WERE NOTED IN RECORD RE-REVIEW, GRAFT ID (B)(4) WAS MANUFACTURED TO SPECIFICATION PRIOR TO DISTRIBUTION; AND THE COMPLEX NATURE OF THE SURGICAL PROCEDURE, IT IS MORE PLAUSIBLE THAT THE PATIENT'S SURGICAL OUTCOME WAS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.

    Description of Event or Problem · 1

    (B)(4) AND TUTOGEN MEDICAL (B)(4), A WHOLLY OWNED SUBSIDIARY OF (B)(4) RECEIVED A COMPLAINT ON 05/05/2015 REPORTING A TUTOMESH GRAFT WAS UTILIZED IN A THORACIC WALL REPLACEMENT PROCEDURE AND REMOVAL OF 4 RIBS ON (B)(6) 2015. THE GRAFT WAS IMPLANTED WITH TENSION ONTO SURROUNDING RIBS. APPROXIMATELY TWO WEEKS POST OPERATIVELY, THE PATIENT UNDERWENT REVISION OF A HEMATOMA. DURING THE PROCEDURE, IT WAS NOTED THAT THE GRAFT HAD RUPTURED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2015. THE COMPLAINT NOTIFICATION INDICATED THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SARCOMATOID DIFFERENTIATED PULMONARY CARCINOMA WITH NO IRRADIATION THERAPY INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363593 TUTOMESH BOVINEPERICARDIUM SURGICAL MESH FTM TUTOGEN MEDICAL GMBH NZ17160410

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention NOT PROVIDED.