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

Catalog Number	ERSF-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ptosis (2620)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
General conclusion: device involvement: a causal relationship between the reported event and the device has/has not been established.Event characterization: the event was classified as not confirmed.Clinical confirmation: upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported case was not confirmed.Root cause analysis: 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.Dfu and labeling evaluation: the event is a known, well-documented complication associated with silicone breast implants.It is clearly addressed in the product¿s directions for use (dfu), which states: symmastia ¿ this is a relatively rare implant-displacement problem that occurs when the skin and muscle between the breasts over the sternum (breastbone) detaches, and the two pockets of tissue that hold the breast implants come together to form one pocket.This allows the implants to come together in the middle, creating the appearance of a ¿uniboob¿ and sometimes causing discomfort or pain.It¿s often difficult to correct symmastia and it may require more than one surgery.In most cases, surgery will involve removing the implants and replacing them with new (usually smaller) implants.The dfu also emphasizes the responsibility of the surgeon to fully inform the patient of potential risks and complications during the pre-operative consultation.Patients are provided with the document ¿motiva implants®: information for the patient,¿ accessible at ifu.Motiva.Health.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.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.
Event or Problem Description
Usa.Allegedly, a patient had motiva implants in (b)(6) 2025, and her implants have migrated medially, creating a partial symmastia.A revision surgery is scheduled.No patient demographics, such as weight, or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
General conclusion: device involvement: a causal relationship between the reported event and the device has been established.Event characterization: the event was classified as symmetrica.Clinical confirmation: upon thorough evaluation of the submitted clinical documentation and supporting evidence, the symmetrica was confirmed.Root cause analysis: based on the investigation performed the root cause of the reported event could not be determined.Dfu and labeling evaluation the alleged event is a known, well-documented complication associated with silicone breast implants.It is clearly addressed in the product¿s directions for use (dfu), which states: symmetrica ¿ this is a relatively rare implant-displacement problem that occurs when the skin and muscle between the breasts over the sternum (breastbone) detaches and the two pockets of tissue that hold the breast implants come together to form one pocket.This allows the implants to come together in the middle, creating the appearance of a ¿uniboob¿ and sometimes causing discomfort or pain.It¿s often difficult to correct symmetrica and it may require more than one surgery.In most cases, surgery will involve removing the implants and replacing them with new (usually smaller) implants.The dfu also emphasizes the responsibility of the surgeon to fully inform the patient of potential risks and complications during the pre-operative consultation.Patients are provided with the document ¿motiva implants®: information for the patient,¿ accessible at ifu.Motiva.Health.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.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.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: ERGONOMIX ROUND SMOOTHSILK
• 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: 23581807
• Report Number: 3012883202-2025-01470
• Device Sequence Number: 15797224
• Product Code: FTR
• UDI-Device Identifier: 07445161010810
• UDI-Public: (01)07445161010810(11)241122(17)291122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/06/2026

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: ERSF-500
• Device Lot Number: 24111490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female