BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH, SURGICAL (SOFT TISSUE PATCH) RIGHT

    MDR report key: 25243848 · Received May 20, 2026

    Report

    Report Number
    MW5188533
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Report Date
    May 14, 2026
    Manufacturer
    RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. ((B)(6) REF (B)(4)). ALLEGED EVENT: PATIENT REPORTED IMPLANTATION WITH CORTIVA ACELLULAR DERMAL MATRIX DURING RIGHT BREAST RECONSTRUCTION SURGERY. PATIENT THEN UNDERWENT REVISION RECONSTRUCTION DUE TO "LATERALIZATION OF THE IMPLANTS." CORTIVA IS A (B)(6) PRODUCT. DEVICE CODE: 4003. PATIENT CODE: 4580. REFERENCE REPORT MW5188534. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417175 MESH, SURGICAL (SOFT TISSUE PATCH) RIGHT MESH, SURGICAL FTM RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1