MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; MOTIVA ERGONOMIX ROUND SILKSURFACE

Catalog Number	ERSD-360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As stated in the literature: the human breast is not a sterile anatomic structure; it contains endogenous flora, derived from the nipple ducts, that is essentially similar to that found in normal skin.Multiple breast ducts provide a passage from the skin surface to deep within the breast tissue.¿(pittet et al, 2005).As stated in the literature: ¿early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.¿ (sforza, et al.2017).¿seroma can present both early and late, with the latter being recently linked with malignant growths and prolonged onset.¿ (sforza, et al.2017).¿the human breast is not a sterile anatomic structure; it contains endogenous flora, derived from the nipple ducts, that is essentially similar to that found in normal skin.Multiple breast ducts provide a passage from the skin surface to deep within the breast tissue.¿(pittet et al, 2005)."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 determinate 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 for the section of surgical precautions as follows: infection: "signs of acute infection reported in association with breast tissue expanders include edema, erythema, tenderness, pain, and fever.As with other invasive surgeries, toxic shock syndrome (tss), a life-threatening condition, has been reported in rare instances following breast implant surgery.Symptoms of tss occur suddenly and can include high fever (102°f (38.8°c) or higher), vomiting, diarrhea, sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should immediately contact their physician for diagnosis and treatment if any of these symptoms occur." in addition, a review of the device history record was conducted, and it was concluded that there were no deviations in the manufacturing process of this device that would have caused or contributed to this incident.
Event or Problem Description
Argentina.It was reported that a patient who underwent implantation surgery in (b)(6) 2025, required an explantation ten days after due to a skin infection.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
A causal relationship between the reported event and the device has been established.Upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported infection was confirmed.This event is a well-documented complication inherent to breast implant surgery.Based on the analysis of the available data, including clinical findings and product traceability records, there is no evidence indicating a causal link between this specific case and any product-related factors, including raw materials or manufacturing processes.The etiology of the alleged event is recognized as multifactorial, given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to the manufacturing process and/or the product itself.A comprehensive review of the device history record (dhr) for the affected lot was completed.No deviations, non-conformances, or anomalies were identified during manufacturing.All raw materials and process parameters conformed to specified quality requirements.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 device rupture 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.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: MOTIVA ERGONOMIX ROUND SILKSURFACE
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela ; 8003554164
• MDR Report Key: 22162869
• Report Number: 3012883202-2025-00793
• Device Sequence Number: 8683306
• Product Code: FTR
• UDI-Device Identifier: 07445161010599
• UDI-Public: (01)07445161010599(11)241129(17)291129
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ERSD-360
• Device Lot Number: 24111842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female