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

Model Number	3542680
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: according to the information received, the patient experienced deflation in the breast implant.The product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant had parallel lines of shell wear on the posterior aspect, in addition, a tear was noticed within the shell wear measuring approximately 5.5 cm.The evaluation determined that the cause of the rupture is consistent with normal wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the continuous and sustained stresses to the device.It should be noted that as part of the mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Reason for device explant and/or reoperation: breast prosthesis deflation.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 43-year-old caucasian female patient underwent a primary breast augmentation procedure with mentor siltex round moderate profile 475cc saline breast prostheses that both deflated post implantation.Bilateral deflation was diagnosis by a healthcare professional.Additionally, the patient developed capsular contracture (baker grade unknown) in her right breast post implantation.As a result, the patient underwent bilateral explantation and replacement with mentor smooth round moderate profile 425cc saline breast prostheses on (b)(6) 2022.This medwatch report is for the patient¿s left breast prosthesis.Refer to manufacturer report number 1645337-2022-10353 for the report for the patient¿s right breast prosthesis.

• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15597390
• Report Number: 1645337-2022-12191
• Device Sequence Number: 14007057
• Product Code: FWM
• UDI-Device Identifier: 00081317001836
• UDI-Public: 00081317001836
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2003
• Device Model Number: 3542680
• Device Catalogue Number: 3542680
• Device Lot Number: 187924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/1999
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White