BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID

    MDR report key: 20820333 · Received December 2, 2024

    Report

    Report Number
    3012883202-2024-00167
    Event Type
    Injury
    Date Received
    December 2, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    UDI-DI
    07445161012395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    · AN EVALUATION OF THE REPORT WAS EXECUTED AND IT WAS NOT POSSIBLE TO CONFIRM AN EXTRUSION DUE TO NO CLINICAL EVIDENCE WAS PROVIDED. THERE WAS NOT A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. · A COMPLETE REVIEW OF THE DHR FOR LOT 22111398 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESSES. THE REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. ¿ · A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. · AS NO MANUFACTURING, MATERIAL OR DESIGN ISSUES WERE IDENTIFIED, NO FURTHER INVESTIGATION OR ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. ¿ · ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.

    Additional Manufacturer Narrative · 0

    EXTRUSION REPRESENTS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF BREAST IMPLANTS, IT INVOLVES THE IMPLANT COMING THROUGH THE SKIN, NORMALLY THROUGH THE INCISION WHERE IT¿S BEEN PLACED. EXTRUSION CAN HAPPEN FOR SEVERAL REASONS, SUCH AS THE SKIN OVER THE IMPLANT THINNED TOO MUCH LEAVING TOO LITTLE COVERAGE FOR THE IMPLANT, THE IMPLANT USED IS TOO LARGE, THE INCISION DID NOT HEAL WELL AND BROKE OPEN. IMPLANT EXPOSURE DUE TO POOR TISSUE COVERAGE FREQUENTLY OBLIGATES THE SURGEON TO REMOVE THE BREAST IMPLANT AND BEGIN ANEW (GARGANO, CIMINELLO & DE SANTIS; 2009). PER OUR DIRECTIONS FOR USE, EACH PATIENT MUST RECEIVE THE ESTABLISHMENT LABS S.A. ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT¿ DURING HER SURGICAL CONSULTATION, IT IS THE SURGEONS´ RESPONSIBILITY TO ENSURE THAT THE PATIENT COMPLETELY UNDERSTANDS THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY, AS WELL AS THE COMPLICATIONS TYPICAL OF ANY TYPE OF SURGERY. THIS DOCUMENT IS AVAILABLE IN MOTIVA® WEBSITE: IFU.MOTIVA.HEALTH THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED TO DETERMINE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE ON THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: "BREAST IMPLANT EXTRUSION, OR BREAST IMPLANT EXPOSURE, OCCURS WHEN THE BREAST SKIN AND TISSUES THAT ARE HOLDING THE IMPLANT FAIL, CAUSING THE IMPLANT TO PROTRUDE THROUGH THE SKIN AND BECOME EXPOSED. IT HAPPENS IN LESS THAN 2% OF PATIENTS; IT IS SHORTLY AFTER BREAST AUGMENTATION OR DOWN THE ROAD. BREAST-IMPLANT EXTRUSION CAN OCCUR FOR VARIOUS REASONS, SUCH AS IMPROPER WOUND HEALING DUE TO AN INFECTION, TRAUMA, TOO LITTLE SOFT-TISSUE COVERAGE, OVERSIZED IMPLANT COUPLED WITH TOO LITTLE TISSUE COVERAGE, OR LACK OF BLOOD SUPPLY. BREAST-IMPLANT EXTRUSION CALLS FOR SURGERY AND REMOVAL OF THE IMPLANT. ALSO, A COMPLETE REVIEW OF THE DHR WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE PROCESS, SO IT IS ESTABLISHED THAT THERE IS NO EVIDENCE OF A RELATIONSHIP BETWEEN THE EVENT AND THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED AN EXTRUSION OF THE PROSTHESIS. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304887 MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID MOTIVA IMPLANTS FTR MOTIVA USA LLC 22111398 07445161012395

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other