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

Catalog Number	RSF-500+
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.Allegedly, a patient who underwent a breast surgery augmentation on (b)(6) 2025 presents her left breast implant flipped.A revision surgery was required to perform a breast capsulorrhaphy with implant repositioning.The investigation is in process.
Additional Manufacturer Narrative
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: rotation: "anterior/posterior rotation, also called flipping, has been observed more frequently with cohesive gel implants.The flat base of the implant is positioned anteriorly, deforming the breast of the patient.Proper placement and pocket dissection reduce the risk of occurrence.Flipping can be treated with bimanual manipulation in the office and can be done repeatedly in recurrent cases.However, in some cases, revision surgery may be necessary to reduce pocket dimensions".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.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: SMOOTHSILK PLUS
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; 8003554164
• MDR Report Key: 24571909
• Report Number: 3012883202-2026-02066
• Device Sequence Number: 20924179
• Product Code: FTR
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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-500+
• Device Lot Number: 25010375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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