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

Model Number	3501490
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/01/2022
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.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.Reason for device explant and/or reoperation: deflation, anisomastia date of explantation: (b)(6) 2023 manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 58-year-old caucasian female patient underwent a primary breast augmentation surgery with implantation of a 575cc mentor smooth round spectrum saline breast implant prosthesis.Post-operatively, the patient underwent a breast lift operation for an undisclosed reason.Afterwards, she had mammogram imaging performed which was stated to have caused a deflated left breast implant.As a result, the patient is scheduled for bilateral removal and replacement with 575cc mentor smooth round spectrum saline breast implants on (b)(6) 2023.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2023-04990 for the contralateral event.
Additional Manufacturer Narrative
On may 19, 2023, the mentor analysis lab received the suspect medical device for evaluation.On june 01, 2023, mentor completed an evaluation on the returned device.The product was returned to mentor for evaluation, but the tubing, the connector, and the injection dome were not returned.Mentor then conducted a visual inspection and leak testing of the device.Visual analysis of the returned sample revealed that no damage was observed on the breast implant.Leak testing was performed in accordance with mentor procedures, and a tear was observed on the posterior view, measuring approximately less than 0.1 cm.Additionally, no other leak sites were detected.The evaluation determined that the cause of the deflation is the trauma experienced.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Trauma is a known inherent risk of saline-filled mammary prosthesis.Manufacturer¿s reference number: (b)(4).

• 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: 16833921
• Report Number: 1645337-2023-04991
• Device Sequence Number: 16960020
• Product Code: FWM
• UDI-Device Identifier: 00081317002048
• UDI-Public: 00081317002048
• 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: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03/24/2009
• Device Model Number: 3501490
• Device Catalogue Number: 3501490
• Device Lot Number: 5594321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2005
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White