BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA

    MDR report key: 12666196 · Received October 20, 2021

    Report

    Report Number
    3002924436-2021-00030
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 14, 2021
    Report Date
    June 22, 2022
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS REVIEW INDICATED THAT SERIAL ID (B)(6) WAS MANUFACTURED TO SPECIFICATION - SP-61100 "04"; ANNEX 1-3 "06"; ANNEX 1-6 "02" AND MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. TO DATE, RTI GERMANY HAS MANUFACTURED AND DISTRIBUTED 15 FORTIVA® TISSUE MATRIX XENOGRAFT FROM LOT PD19400001 WITHOUT RELATED COMPLAINTS. BLEEDING AFTER A SURGERY IS A COMMON POST-OPERATIVE COMPLICATION. FOR THIS COMPLAINT, THE BLEEDING AND PROCEDURE OCCURRED ON THE SAME DAY. BASED ON THE ADDITIONAL INFORMATION THAT WAS PROVIDED, THE PATIENT'S POST-OPERATIVE BLEEDING WAS EXCLUSIVELY RELATED TO THE SURGICAL PROCEDURE AND NOT WITH THE FORTIVA® XENOGRAFT.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT BREAST RECONSTRUCTION POST-MASTECTOMY WITH NIPPLE CONSERVING INFRAMAMMARY. A SILICONE IMPLANT WAS PLACED AND FOUR LYMPH NODES WERE REMOVED. TWO DRAINS REMAINED INDWELLING. ON THE SAME DAY, THE PATIENT EXPERIENCED BLEEDING AND WAS TAKEN BACK TO THE OPERATING ROOM FOR TREATMENT THAT WAS SUCCESSFUL. BOTH DRAINS WERE REMOVED UPON DISCHARGE FROM THE HOSPITAL ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, IT IS UNKNOWN IF THE GRAFT REMAINS IMPLANTED. A COMPREHENSIVE RECORDS RE-REVIEW IS BEING CONDUCTED. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED A COMPLAINT AS PART OF THE FORTIVA APPEAR STUDY. THE COMPLAINT INDICATED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE, ON AN UNKNOWN DATE, WITH IMPLANTATION OF AN RTI FORTIVA GRAFT. ON (B)(6) 2021, THE PATIENT DEVELOPED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560726 FORTIVA PORCINE, DERMIS FTM TUTOGEN MEDICAL, GMBH PD19400001

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other