MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Capsular Contracture (1761)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: autoimmune disorder, capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast reconstruction with two 225cc mentor smooth round spectrum prostheses and experienced bilateral capsular contracture (unknown grade) and autoimmune disorder postoperatively.The patient suffered several unexplained systemic symptoms, including joint pain (b)(6), muscle pain (b)(6) 2020, weakness (b)(6) 2020, breast pain, itching, joint stiffness, fatigue, muscle ache, pulsation sensation, bradycardia, burning sensation, finger swelling, tinnitus, ebv, vertigo, sweating, sleeping difficulty, dry eyes, dry mouth, metallic taste in mouth, not able to focus, weight loss, and headaches.The patient sated that she was diagnosed with fibromyalgia on (b)(6) 2021.No device issue was reported.The root cause of the patient¿s symptoms is unclear.As a result, the patient underwent bilateral removal without replacement on (b)(6) 2021.The patient reported the event to fda via mw5101770.This report is for the right-sided prosthesis.

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12485327
• Report Number: 1645337-2021-10360
• Device Sequence Number: 3936510
• Product Code: FWM
• UDI-Device Identifier: 00081317001973
• UDI-Public: 00081317001973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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 Expiration Date: 11/16/2022
• Device Model Number: 3501430
• Device Catalogue Number: 3501430
• Device Lot Number: 7654830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/16/2021
• 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: 68 YR