BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA PORCINE DERMIS

    MDR report key: 11720423 · Received April 23, 2021

    Report

    Report Number
    3002924436-2021-00009
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    May 22, 2021
    Report Date
    October 29, 2021
    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 LOT PD1810001. NO DEPARTURES FROM STANDARD OPERATING PROCEDURES WERE NOTED DURING THE RECORDS RE-REVIEW THAT WOULD NEGATIVELY IMPACT THE MANUFACTURING OF PORCINE DERMIS XENOGRAFTS FROM THE LOT. MANUFACTURING RECORDS REVIEW INDICATED THAT SERIAL ID (B)(6) MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. TO DATE, RTI GERMANY HAS MANUFACTURED AND DISTRIBUTED 51 FORTIVA DERMIS GRAFTS FROM THE LOT WITHOUT RELATED COMPLAINTS. THE DEVELOPMENT OF RED BREAST SYNDROME IS A WELL KNOWN PHENOMENON FOLLOWING BREAST RECONSTRUCTION AFTER MASTECTOMY WITH FORTIVA GRAFT IMPLANTED. HOWEVER, RED BREAST SYNDROME MAY ALSO BE TRIGGERED BY A SEROMA, HEMATOMA, INFECTION, RADIATION, VASCULAR INSUFFICIENCY AND HYPERSENSITIVITY REACTIONS TO SPECIFIC MATERIALS. THE PATIENT DEVELOPED RED BREAST SYNDROME APPROXIMATELY 10 MONTHS POST-OPERATIVELY. IT IS MORE PLAUSIBLE THAT THE PATIENT'S ADVERSE EVENT WAS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.

    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 THE PATIENT UNDERWENT A NIPPLE CONSERVING INFRAMAMMARY LEFT AND RIGHT MASTECTOMY ON (B)(6) 2020. FIVE LYMPH NODES WERE REMOVED FROM THE RIGHT SIDE. NO LYMPH NODES WERE REMOVED ON THE LEFT SIDE. THE PATIENT UNDERWENT A BILATERAL BREAST RECONSTRUCTION WITH IMPLANTATION OF TWO FORTIVA GRAFTS AND TWO SILICONE IMPLANTS. THREE DRAINS WERE PLACED. ONE DRAIN WAS REMOVED ON (B)(6) 2020 AND THE OTHER TWO DRAINS WERE REMOVED ON (B)(6) 2020. ON (B)(6) 2021, APPROXIMATELY 10 MONTHS POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL RED BREAST SYNDROME, PAIN AND BILATERAL SEROMAS THAT RESOLVED ON (B)(6) 2021. SHE WAS TREATED WITH CLINDAMYCIN 600MG ON (B)(6) 2021. SHE UNDERWENT SEROMA PUNCTURES ON (B)(6) 2021. THE SEROMAS RESOLVED ON (B)(6) 2021 WITH NO RESIDUAL EFFECTS. IN EARLY (B)(6) 2021, THE PATIENT RECEIVED A COVID VACCINATION. HER SYMPTOMS FOLLOWING THE VACCINATION CONSISTED OF REDNESS, SWELLING, PAIN IN HER BREASTS, RESTRICTED MOVEMENT OF HER ARMS AND PAIN IN HER LIMBS. ON (B)(6) 2021, THE PATIENT WAS TREATED WITH PARACETAMOL FOR 3-4 DAYS. HER SYMPTOMS RESOLVED WITH NO RESIDUAL EFFECTS.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIERS WERE NOT PROVIDED IN ORDER TO CONDUCT A COMPREHENSIVE RECORDS RE-REVIEW. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI, RECEIVED A COMPLAINT AS PART OF THE FORTIVA APPEAR TRIAL. THE REPORTED COMPLAINT INDICATED THAT A PATIENT UNDERWENT IMPLNATATION OF A FORTIVA GRAFT FOR BREAST RECONSTRUCTION ON AN UNKNOWN DATE. ON (B)(6) 2020 THE PATIENT DEVELOPED A SEROMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616823 FORTIVA PORCINE DERMIS SURGICAL MESH FTM TUTOGEN MEDICAL, GMBH PD1810001

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other