BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MENTOR IMPLANT

    MDR report key: 16138738 · Received January 11, 2023

    Report

    Report Number
    1645337-2023-00356
    Event Type
    Injury
    Date Received
    January 11, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, AESTHETIC DISSATISFACTION, ADDITIONAL UNSPECIFIED COMPLICATIONS. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: ADLER N, CARMON E, HOURI P. REVISION RATE OF DIRECT-TO-IMPLANT BREAST RECONSTRUCTION: IS IT TRULY A SINGLE-STAGE RECONSTRUCTION? A SINGLE-SURGEON EXPERIENCE. AESTHETIC PLAST SURG. 2022 OCT 28. DOI: 10.1007/S00266-022-03136-7. EPUB AHEAD OF PRINT. PMID: 36307562. OBJECTIVE/METHODS/STUDY DATA: THE GOAL OF THIS STUDY WAS TO FOCUS ON THE RE-OPERATION RATE OF DIRECT-TO-IMPLANT (DTI) IN COMPARISON WITH TWO-STAGE TISSUE EXPANDER (TE) RECONSTRUCTION. IN TOTAL, 165 CONSECUTIVE PATIENTS (222 BREASTS) UNDERWENT A SKIN-SPARING MASTECTOMY AND IMMEDIATE IMPLANT-BASED RECONSTRUCTION BETWEEN JANUARY 2010 AND DECEMBER 2019. PATIENTS WERE DIVIDED INTO TE PROCEDURE AND DTI (42,180 BREASTS, RESPECTIVELY). LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: MENTOR TEXTURED IMPLANTS & SMOOTH ROUND TISSUE EXPANDERS OTHER MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: ALLODERM. THE FOLLOWING COMPLICATIONS WERE REPORTED: 29 (13.1%) PATIENTS EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE NOT SPECIFIED). 30 (13.5%) PATIENTS HAD RE-OPERATION DUE TO COMPLICATIONS. 98 (44.14%) PATIENTS HAD RE-OPERATION DUE TO AESTHETIC DISSATISFACTION. THIS MEDWATCH REPORT HAS BEEN DEFAULTED TO TISSUE EXPANDER DUE TO UNKNOWN TYPE, AND THE COMMON DEVICE NAME AND PROCODE ARE BEING REPORTED FOR SUBMISSION PURPOSES ONLY. THE LITERATURE SOURCE DID NOT SPECIFY WHEN ADVERSE EVENTS OCCURRED (WHEN PATIENTS HAD TISSUE EXPANDERS IMPLANTED OR WHEN PATIENTS HAD GEL BREAST PROSTHESES IMPLANTED.) IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. ADDITIONALLY, THE GEL BREAST PROSTHESES DISTRIBUTED IN ISRAEL ARE MANUFACTURED BY MENTOR¿S FACILITY IN LEIDEN, THE NETHERLANDS. THESE DEVICES ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES DO NOT APPEAR TO MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. AS A RESULT, NO MDR REPORT IS REQUIRED FOR THE MENTOR GEL BREAST PROSTHESES USED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471800 UNKNOWN MENTOR IMPLANT EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention