MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 66-year-old caucasian female patient underwent revision breast augmentation with 325cc mentor siltex round moderate profile on both sides and experienced breast implant deflation on her left side postoperatively; diagnosed in the office.The patient has consulted with the healthcare professional.As a result, the patient is scheduled for surgery on (b)(6) 2024.On august 20, 2024, mentor became aware that the patient also experienced right side capsular contracture; baker grade iv in addition to right side deflation and underwent bilateral replacement surgery on (b)(6) 2024.Per information received on august 22, 2024, mentor became aware that the replacement devices used on (b)(6) 2024 were serial numbers (b)(6) on the left side, and (b)(6) on the right side.Mentor is aware that the date of implant is before the manufacture date of lot 94052.Follow ups were performed and no information has been received so far regarding the discrepancy.If any clarification or information is received in the future, a supplemental report will be submitted.This medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.On august 26, 2024, photo evaluation was completed as follows: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.On august 29, 2024, device evaluation was completed as follows: mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the sal siltex rnd diap pkg 325cc returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body's individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsules, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Reason for device explant and/or reoperation: right capsular contracture; baker grade iv manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 20115542
• Report Number: 1645337-2024-10117
• Device Sequence Number: 20694667
• Product Code: FWM
• UDI-Device Identifier: 00081317001799
• UDI-Public: 00081317001799
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 3542650
• Device Lot Number: 94052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/1994
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White