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

Catalog Number	ERSD-265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pain is a common and known reason for complaints, and it is clearly characterized in the product dfu included with the implant, as stated above.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: "most women undergoing augmentation or reconstruction with a mammary implant will experience post-operatory breast and/or chest pain.While this pain usually recedes in most women as they heal after surgery, it can become a chronic problem in other women.Hematoma, migration, infection, implants that are too large or capsular contracture can cause chronic pain.Sudden, severe pain may be associated with implant rupture.The surgeon should instruct the patient to immediately report if there is significant pain or if pain persists".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.Device involved is pending to be returned for evaluation.
Event or Problem Description
Usa- it was reported that a surgeon didn't listen to size that patient wanted and this size causing physical pain.The explant surgery 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.
Additional Manufacturer Narrative
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 not been established.¿ event characterization: the event was classified as unsatisfactory results.The reported case was not confirmed.Customer states that "this patient did not have a ¿circumstance¿ or ¿failure of product¿.3.Device history record (dhr) review 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.4.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 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 ERGONOMIX ROUND SMOOTHSILK
• Common Device Name: MOTIVA IMPLANTS
• 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: 22005706
• Report Number: 3012883202-2025-00670
• Device Sequence Number: 12539870
• Product Code: FTR
• UDI-Device Identifier: 07445161010544
• UDI-Public: (01)07445161010544(11)241027(17)291027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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-265
• Device Lot Number: 24101741
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2024
• 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: Other
• Patient Sex: Unknown