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

Catalog Number	3501440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent primary breast augmentation with two 275cc mentor smooth round spectrum saline breast prostheses.Post-operatively, the patient was diagnosed, via physical examination, with left breast implant deflation.As a result, the patient underwent bilateral breast implant removal and replacement surgery on (b)(6) 2023.The replacement devices were: (left) 325cc mentor memorygel breast implant catalog: 3503251bc lot: 9948732 sn: (b)(6) and (right) 325cc mentor memorygel breast implant catalog: 3503251bc lot: 9948732 sn: (b)(6).
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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: material rupture.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).
Additional Manufacturer Narrative
On january 5, 2024, mentor received additional information indicating that the patient was also diagnosed with breast deformity and bilateral breast implant deflations during the removal surgery on (b)(6) 2023.This medwatch form is for the left breast prosthesis.Deflation on the right breast implant will be reported under mrn: 1645337-2024-00754.
Additional Manufacturer Narrative
On january 5, 2024, mentor received additional information indicating that the patient was also diagnosed with breast deformity and bilateral breast implant deflations during the removal surgery on (b)(6) 2023.This medwatch form is for the left breast prosthesis.Deflation on the right breast implant will be reported under mrn: 1645337-2024-00754.

• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18452381
• Report Number: 1645337-2024-00228
• Device Sequence Number: 15193380
• Product Code: FWM
• UDI-Device Identifier: 00081317001980
• UDI-Public: 00081317001980
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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: 03/31/2005
• Device Catalogue Number: 3501440
• Device Lot Number: 224317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/05/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/19/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2001
• 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: 58 YR
• Patient Sex: Female