BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA

    MDR report key: 12963698 · Received December 8, 2021

    Report

    Report Number
    3002924436-2021-00035
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    September 22, 2021
    Report Date
    August 10, 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

    RTI GERMANY CONDUCTED A BATCH DOCUMENTATION REVIEW FOR SERIAL ID (B)(6) MANUFACTURED FROM DONOR PD18300001. ONE DEPARTURE FROM STANDARD OPERATING PROCEDURES WAS NOTED DURING THE RECORDS RE-REVIEW FOR DONOR PD18300001 (NC 18 38 074: EXCEEDANCE OF DRYING TEMPERATURE (0,7°C) - NO IMPACT ON PRODUCT QUALITY). MANUFACTURING RECORDS REVIEW INDICATED THAT SERIAL ID (B)() WAS MANUFACTURED TO SPECIFICATION AND MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. TO DATE, RTI GERMANY HAS MANUFACTURED AND DISTRIBUTED 24 FORTIVA® DERMAL XENOGRAFTS FROM LOT PD18300001. THERE ARE THREE RELATED COMPLAINTS FOR SEROMA DEVELOPMENT ASSOCIATED WITH THE LOT AND THE FORTIVA® CLINICAL STUDY (MDR 3002924436-2021-00009, 3002924436-2021-00033 AND 3002924436-2022-00003).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED ADDITIONAL INFORMATION AS PART OF THE FORTIVA APPEAR TRIAL. THE FOLLOWING INFORMATION INDICATED THAT THE PATIENT UNDERWENT A NIPPLE CONSERVING INFRAMAMMARY MASTECTOMY ON (B)(6) 2021. THREE LYMPH NODES WERE REMOVED ON THE RIGHT SIDE. A SILICONE IMPLANT WAS ALSO PLACED. TWO DRAINS REMAINED INDWELLING. ONE DRAIN WAS REMOVED ON 09/09/2021. THE SECOND DRAIN WAS REMOVED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT DEVELOPED A 115CC MAJOR SEROMA THAT WAS ASPIRATED THE SAME DAY. THE PATIENT'S ADVERSE EVENT RESOLVED ON (B)(6) 2021.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859071 FORTIVA PORCINE DERMIS FTM TUTOGEN MEDICAL, GMBH PD18300001

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other