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

Model Number	3501480
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old hispanic female patient, who's undergone primary breast augmentation with two 475cc mentor smooth round spectrum saline breast prostheses, suffered spontaneous bilateral breast implant deflations and discomfort, post-procedure.Ct scan confirmed the deflations.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the complaint device.The manufacturing record evaluation (mre) was reviewed, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the patient was also diagnosed with breast hypoplasia, breast asymmetry, and only right breast deflation.No indication of a left breast implant deflation.However, on (b)(6) 2021, per mammogram, the patient was also diagnosed with bilateral breast implant site calcifications, and left breast fat necrosis.As a result, the patient underwent bilateral implants removal and replacement on (b)(6) 2021.The replacement devices were the following.(left) 350cc mentor memorygel breast implant catalog: 3503504bc lot: 9556193 sn: (b)(6) and (right) 400cc mentor memorygel breast implant catalog: 3504004bc lot: 9535794 sn: (b)(6).In addition, the explanted devices were discarded.The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Reason for device explant and/or reoperation: breast pain, calcification, material rupture.

• 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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11968443
• Report Number: 1645337-2021-06533
• Device Sequence Number: 14588469
• Product Code: FWM
• UDI-Device Identifier: 00081317002024
• UDI-Public: 00081317002024
• 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: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2018
• Device Model Number: 3501480
• Device Catalogue Number: 3501480
• Device Lot Number: 6888409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 12/13/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/29/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2014
• 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; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic