BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA

    MDR report key: 15440673 · Received September 16, 2022

    Report

    Report Number
    3002924436-2022-00015
    Event Type
    Injury
    Date Received
    September 16, 2022
    Report Date
    November 7, 2022
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE IDENTIFIERS WERE NOT PROVIDED. ADDITIONAL INFORMATION REQUESTED. ONCE ALL REQUESTED INFORMATION HAS BEEN RECIEVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE GRAFT WAS NOT AVAILABLE FOR RETURN. THE REVIEW OF THE BATCH DOCUMENTATION AND FREQUENCY INVESTIGATION COULD NOT BE CARRIED OUT DUE TO MISSING PRODUCT AND PATIENT DATA. THE PUBLICATION BY KLINGER ET AL. 2022 DESCRIBES TWO POST-OPERATIVE COMPLICATIONS AFTER BREAST RECONSTRUCTION USING SILICONE IMPLANTS AND FORTIVA. INDIVIDUAL PATIENT DATA WAS NOT PROVIDED IN THE PUBLICATION, THEREFORE, THIS CASE REFERS TO MULTIPLE PATIENTS. THIS CASE IS CONSIDERED NON-SERIOUS AS NO SERIOUSNESS CRITERION HAS BEEN DESCRIBED FOR THE TWO EVENTS (SKIN ISCHEMIA AND WOUND DEHISCENCE) IN THE PUBLICATION. NO CAUSALITY ASSESSMENT FOR BOTH EVENTS WAS PROVIDED BY THE AUTHOR, HOWEVER, FROM THE CONTEXT OF THE WHOLE ARTICLE IT MAY BE ASSUMED THAT BOTH EVENTS ARE CONSIDERED RELATED TO THE PROCEDURE MEANING THE SURGERY (INCLUDING THE ADDITIONAL USE OF AN ACELLULAR DERMAL MATTRIX (ADM) AND NOT THE ADM ITSELF. RTI SURGICAL GERMANY CONSIDERS BOTH EVENTS AS RELATED TO THE PROCEDURE AND NOT THE RELATED TO THE FORTIVA. DESPITE SEVERAL ATTEMPTS, TO FOLLOW-UP NO ADDITIONAL INFORMATION WAS PROVIDED. RTI SURGICAL GERMANY CONSIDERS THE CASE CLOSED.

    Description of Event or Problem · 0

    ON 08/17/2022, RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ORIGINATING FROM A LITERATURE SEARCH; KLINGER F. ET.AL., 2022, 'IMMEDIATE DIRECT-TO-IMPLANT BREAST RECONSTRUCTION: A SINGLE CENTER COMPARISON BETWEEN DIFFERENT PROCEDURES', FRONTIERS IN SURGERY. THIS IS THE FIRST STUDY USING FORTIVA® IN PREPECTORAL BREAST RECONSTRUCTION. IT IS A RETROSPECTIVE DATA ANALYSIS OF PATIENTS WHO UNDERWENT MASTECTOMY FOLLOWED BY IMMEDIATE BREAST RECONSTRUCTION WITH SILICONE IMPLANTS AND COMPARES THE OUTCOMES OF THREE PATIENT POPULATIONS: RETROMUSCULAR PROSTHESIS, PREPECTORAL PROSTHESIS AND PREPECTORAL PROSTHESIS RECONSTRUCTION WITH ACELLULAR DERMIS MATRIX (ADM). IT WAS SUGGESTED THAT THE LATTER WILL BRING BENEFITS COMPARED TO THE CURRENT STANDARD TECHNIQUE (RETROMUSCULAR). A TOTAL OF 67 PATIENTS UNDERWENT RECONSTRUCTION WITH IMPLANTS (43 WITH RETROMUSCULAR PROSTHESIS, 13 PREPECTORAL AND 11 PREPECTORAL WITH ADM. A SIGNIFICANT LOWER INCIDENCE OF SURGICAL COMPLICATIONS WAS FOUND WITH THE UTILIZATION OF THE ADM IN COMPARISON WITH RETROMUSCULAR. WHEN COMPARING COMPLICATIONS BETWEEN THE THREE GROUPS OF PATIENTS, THERE WERE NO SIGNIFICANT DIFFERENCES THE GROUPS ABOUT INDIVIDUAL COMPLICATIONS. COMPLICATIONS WERE MORE FREQUENT IN THE RETROMUSCULAR RECONSTRUCTION, EXCEPT FOR SEROMA, CAPSULAR CONTRACTURE, AND SKIN ISCHEMIA, WHICH WERE MORE FREQUENT IN THE PREPECTORAL RECONSTRUCTION GROUP WITHOUT ADM. WOUND DEHISCENCE WAS SLIGHTLY MORE FREQUENT IN THE PREPECTORAL RECONSTRUCTION WITH ADM GROUP. THE GROUP WITH ADM DID NOT REPORT PAIN TWELVE MONTHS AFTER SURGERY. IT WAS CONCLUDED THAT PREPECTORAL IMPLANT PLACEMENT WITH ADMS IS A VIABLE OPTION FOR IMPROVING RECONSTRUCTIVE OUTCOMES IN PATIENTS UNDERGOING MASTECTOMY SKIN AND NIPPLE SPARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222042 FORTIVA PORCINE DERMIS FTM TUTOGEN MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other