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

Catalog Number	ERSD-300
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
United states.It was reported that a patient experienced capsular contracture and qualified for coverage.An incorrect implant was reportedly provided to the practice for the replacement procedure.The discrepancy in implant size was not identified prior to implantation, and an implant of unintended size was implanted.As a result, the patient reportedly underwent a reoperation two days later.The investigation remains in progress.

• 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 20113 ; CS 20113
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113 ; 8003554164
• MDR Report Key: 24736016
• Report Number: 3012883202-2026-02161
• Device Sequence Number: 16018693
• Product Code: FTR
• UDI-Device Identifier: 07445161010568
• UDI-Public: (01)07445161010568(11)250220(17)300220
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ERSD-300
• Device Lot Number: 25021685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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