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

Model Number	3501420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Wrinkling (2613)
Date of Event	09/22/2020
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: wrinkling, asymmetry.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a hispanic female patient underwent primary breast reconstruction, as part of glow clinical study, with a (left) 620cc mentor memoryshape breast implant and a (right) 175cc mentor smooth round spectrum.Post-operatively, the patient suffered bilateral breasts wrinkling and also asymmetry on the right breast.As a result, on (b)(6) 2020, the patient underwent bilateral breast fat grafting.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
On march 9, 2022, mentor became aware that the incorrect year of implantation was erroneously indicated in the initial report sent on (b)(6) 2022.The date of implantation was (b)(6) 2020.Section d 6a.Implantation year has been updated with the correct year: 2020.
Additional Manufacturer Narrative
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.

• 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: 13428905
• Report Number: 1645337-2022-01180
• Device Sequence Number: 20171882
• Product Code: FWM
• UDI-Device Identifier: 00081317001966
• UDI-Public: 00081317001966
• 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: 2000
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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: 04/28/2023
• Device Model Number: 3501420
• Device Catalogue Number: 3501420
• Device Lot Number: 7715613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 03/09/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/28/2022; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2019
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Hispanic