MAUDE Adverse Event Report: MOTIVA USA LLC MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID; MOTIVA IMPLANTS

Catalog Number	ERSF-425Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 determine 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 on the section of surgical precautions as follows: "breast implant extrusion, or breast implant exposure, occurs when the breast skin and tissues that are holding the implant fail, causing the implant to protrude through the skin and become exposed.It happens in less than 2% of patients; it is shortly after breast augmentation or down the road.Breast-implant extrusion can occur for various reasons, such as improper wound healing due to an infection, trauma, too little soft-tissue coverage, oversized implant coupled with too little tissue coverage, or lack of blood supply.Breast-implant extrusion calls for surgery and removal of the implant.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.
Event or Problem Description
It was reported an extrusion of the prosthesis.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
· an evaluation of the report was executed and it was not possible to confirm an extrusion due to no clinical evidence was provided.There was not a relationship between the reported event and the device.· a complete review of the dhr for lot 22111398 was carried out, no deviation was found in the manufacturing processes.The review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.¿ · a definitive root cause could not be determined.· as no manufacturing, material or design issues were identified, no further investigation or additional actions are required at this time.¿ · establishment labs will continue to monitor for similar complaints/trends.

• Brand Name: MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID
• Common Device Name: MOTIVA IMPLANTS
• Manufacturer (Section D): MOTIVA USA LLC; 125 east de la guerra street; santa barbara CA 93101
• Manufacturer (Section G): ESTABLISHMENT LABS S.A; building b-25, coyol free zone; alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; 125 east de la guerra street; santa barbara, CA 93101 ; 8003554164
• MDR Report Key: 20820333
• Report Number: 3012883202-2024-00167
• Device Sequence Number: 21011749
• Product Code: FTR
• UDI-Device Identifier: 07445161012395
• UDI-Public: (01)07445161012395(11)221120(17)271120
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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-425Q
• Device Lot Number: 22111398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female