MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; MOTIVA SMOOTHSILK PLUS

Catalog Number	RSF-425+
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.It was reported that a patient that had her breast surgery augmentation on february, presented a wound with an exposed implant and was diagnosed with an infection.She was advised to undergo explantation surgery in may.Efforts to gather additional information are ongoing and the investigation remains in progress.
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)."symptoms of infection usually manifest during the first 2 postoperative weeks, but delayed infections may occur months or even years after the operation" (skandalakis, 2009)."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.
Additional Manufacturer Narrative
Laboratory evaluation was conducted in accordance with internal procedures.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.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.Additionally, upon thorough evaluation of the submitted clinical documentation and supporting evidence, the extrusion and infection was not 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.
Event or Problem Description
Usa.It was reported that a patient that had her breast surgery augmentation on february, presented a wound with an exposed implant and was diagnosed with an infection.She was advised to undergo explantation surgery in may.Efforts to gather additional information were made and the investigation was completed.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: MOTIVA SMOOTHSILK PLUS
• 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: 22323292
• Report Number: 3012883202-2025-00869
• Device Sequence Number: 15651985
• Product Code: FTR
• UDI-Device Identifier: 07445161002136
• UDI-Public: (01)07445161002136(11)241125(17)291125
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: RSF-425+
• Device Lot Number: 24111753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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: Unknown