BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID

    MDR report key: 22064417 · Received May 21, 2025

    Report

    Report Number
    3012883202-2025-00710
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE.¿ (HANDEL, GARCÍA AND WINXTROM, 2013. BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132: 1128.). ¿IT IS IMPERATIVE THAT CAREFUL PLANNING AND EXACTING SURGICAL TECHNIQUE ARE USED TO REDUCE IATROGENIC DAMAGE OF IMPLANTS DURING PRIMARY PLACEMENT AND SUBSEQUENT REOPERATIONS.¿ (HANDEL, GARCÍA AND WINXTROM, 2013. BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132: 1128). BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND IMPLANT RUPTURE IS A RISK ASSOCIATED WITH BREAST SURGERY, WHICH CAN OCCUR AT ANY TIME. ADDITIONALLY, RUPTURE IS A COMMON AND KNOWN REASON FOR COMPLAINTS, AND IT IS CLEARLY CHARACTERIZED IN THE PRODUCT DFU INCLUDED WITH THE IMPLANT, AS STATED ABOVE. ADDITIONALLY, NO CASES OF RUPTURE BECAUSE OF PRODUCT FAILURE HAVE BEEN REPORTED TO ESTABLISHMENT LABS EVER. 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 IMPLANTS CAN POTENTIALLY REMAIN INTACT FOR DECADES IN THE BODY, BUT ALL SUCH DEVICES WILL FAIL AT SOME POINT. BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MOST LIKELY TO OCCUR; THE LONGER THE IMPLANT IS IN PLACE. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS, IMPLANT STRESS, AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE IMPLANT, SUBMUSCULAR RATHER THAN SUB-GLANDULAR LOCATION, THE OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE¿. ALSO, A COMPLETE REVIEW OF THE DHR'S 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. DEVICE INVOLVED IS IN TRANSIT TO THE LAB. TESTING IS GOING TO BE PERFORMED.

    Additional Manufacturer Narrative · 0

    1. OVERVIEW: THE QUALITY DEPARTMENT (PMS) RECEIVED A COMPLAINT INVOLVING A MOTIVA® DEVICE. 2. GENERAL CONCLUSION: DEVICE INVOLVEMENT: A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE HAS BEEN ESTABLISHED. EVENT CHARACTERIZATION: THE EVENT WAS CLASSIFIED AS A DEVICE RUPTURE. 3. TECHNICAL INVESTIGATION SUMMARY: LABORATORY TESTING: LABORATORY EVALUATION WAS CONDUCTED IN ACCORDANCE WITH WI-001048 "PMS LABORATORY TESTING UNITS." KEY FINDINGS INCLUDE: VISUAL INSPECTION: MACROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED CLEAR EVIDENCE OF SHELL RUPTURE. MICROSCOPIC ANALYSIS: UNDER MAGNIFICATION, THE SHELL EXHIBITED TRACE MARKS INDICATIVE OF INTERACTION WITH A SHARP INSTRUMENT. THE MORPHOLOGY OF THESE MARKS CLOSELY MATCHED THOSE REPRODUCED UNDER CONTROLLED LABORATORY CONDITIONS SIMULATING INSTRUMENT-RELATED DAMAGE. THESE FINDINGS DIFFER SIGNIFICANTLY FROM PATTERNS ASSOCIATED WITH SPONTANEOUS RUPTURE (E.G., FATIGUE OR SHELL DEGRADATION). SHELL COMPLIANCE TESTING: MECHANICAL AND MATERIAL INTEGRITY TESTING CONFIRMED THAT THE IMPLANT SHELL MET ALL APPLICABLE INTERNATIONAL SPECIFICATION STANDARDS. REFERENCE: FOR-001037 ¿ COMPLAINT INVESTIGATION UNIT TESTING RESULTS. ROOT CAUSE ANALYSIS: BASED ON THE TESTING RESULTS, THE MOST PROBABLE ROOT CAUSE OF THE IATROGENIC RUPTURE IS A DAMAGE FROM A SHARP SURGICAL INSTRUMENT. SUCH DAMAGE MAY HAVE COMPROMISED THE SHELL¿S INTEGRITY, PREDISPOSING IT TO FAILURE DURING CLINICAL PROCEDURE. 4. DEVICE HISTORY RECORD (DHR) REVIEW: A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AFFECTED LOT WAS COMPLETED. NO DEVIATIONS, NON-CONFORMANCE'S, OR ANOMALIES WERE IDENTIFIED DURING MANUFACTURING. ALL RAW MATERIALS AND PROCESS PARAMETERS CONFORMED TO SPECIFIED QUALITY REQUIREMENTS. 5. TREND AND SIGNAL MONITORING: THE EVENT HAS BEEN EVALUATED AS PART OF ONGOING TREND ANALYSIS ACTIVITIES WITHIN THE PMS PROGRAM. PER THE CURRENT COMPLAINT DATA REPORT: NO ADVERSE OR UNEXPECTED TRENDS RELATED TO THE ALLEGED EVENT HAVE BEEN IDENTIFIED. NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AS PART OF ROUTINE PMS SURVEILLANCE.

    Description of Event or Problem · 0

    KOREA- IT WAS REPORTED THAT A PATIENT VISITED THE CLINIC WITH COMPLAINTS OF PAIN AND DEFORMITY IN THE LEFT BREAST, IMAGING STUDIES CONFIRMED A RUPTURE OF THE SILICONE ON THE LEFT SIDE. IMPLANT REPLACEMENT WAS PERFORMED ON (B)(6) 2025. 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
    45057 MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID MOTIVA IMPLANTS FTR ESTABLISHMENT LABS S.A. ERSD 380Q 16060290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other