MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; SILKSURFACE PLUS WITH QID

Catalog Number	RSD-300+Q
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Mexico.Allegedly, a patient who underwent an augmentation mammoplasty in (b)(6) 2025 had a bilateral early seroma that required draining.The pain persisted due to a capsular contracture.The patient was given treatment and therapy without improvement.A revision surgery was performed.The investigation is in progress.
Additional Manufacturer Narrative
As stated in literature: the most common overall indication for reoperation is capsular contracture.(handel, 2006).Breast prostheses are no different from any foreign material implanted into the human body in the sense of triggering a protective immune reaction from the host.This ¿foreign body response¿ (fbr) is universal and ideally removes or otherwise surrounds the ¿irritant material¿ with fibrous tissue to prevent unwanted immune sequelae.A capsule around a breast implant is, therefore, a necessary mechanism of body defense, but if excessive it can lead to pain and deformity of the breast (steiert, et al., 2013).¿it is imperative that careful planning and exacting surgical technique are used to reduce iatrogenic damage of implants during primary placement and subsequent reoperations.¿ (handel, garcía and winxtrom, 2013).¿early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.¿ (sforza, et al.2017).¿seroma can present both early and late, with the latter being recently linked with malignant growths and prolonged onset.¿ (sforza, et al.2017).Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: capsular contracture: ¿capsular contracture occurs when the capsule tightens and squeezes the implant.This can cause the implant to turn rigid (from slightly firm to quite hard) and the firmest ones can cause varying degrees of discomfort, pain, and palpability.In addition to the firmness, capsular contracture can result in a deformed breast, visible surface wrinkling and/or displacement of the implant.Detection of breast cancer by mammography may also be a more difficult.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.Patients should also be advised that additional surgery might be needed in cases where pain and/or firmness are severe (baker grades iii or iv) and that capsular contracture may happen again after additional surgeries.Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself¿.
Additional Manufacturer Narrative
A causal relationship between the reported event and the device has not been established.Upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported case was not confirmed meeting the requirements for a capsular contracture, classified as baker grade iii/iv.This classification indicates moderate to severe contracture, characterized by firmness, distortion, and potential patient discomfort or pain.Additionally, early seroma could not be confirmed due to lack of clinical evidence.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.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 IMPLANTS
• Common Device Name: SILKSURFACE PLUS WITH QID
• 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: 23783486
• Report Number: 3012883202-2025-01601
• Device Sequence Number: 14709974
• Product Code: FTR
• UDI-Device Identifier: 07445161002709
• UDI-Public: (01)07445161002709(11)230608(17)280608
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: RSD-300+Q
• Device Lot Number: 23060361
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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: Unknown