MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE MODERATE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542911
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2023
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a 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).
Event or Problem Description
It was reported that a patient underwent breast augmentation revision with two unspecified mentor saline breast prostheses.Post-operatively, the patient suffered left breast implant deflation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On april 25, 2024, mentor received additional information indicating that the patient has been scheduled for breast implant removal surgery on (b)(6) 2024.Mentor also received information indicating that the suspect medical device was a 225cc mentor siltex contour profile moderate saline (catalog: 3542911 lot: 5721121).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: material rupture.
Additional Manufacturer Narrative
July 4, 2024, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
On july 25, 2024, the product investigations were completed for two devices of the same lot returned.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the con pro 225/250cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• 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: 18427401
• Report Number: 1645337-2024-00010
• Device Sequence Number: 15386208
• Product Code: FWM
• UDI-Device Identifier: 00081317001850
• UDI-Public: 00081317001850
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: 01/04/2011
• Device Catalogue Number: 3542911
• Device Lot Number: 5721121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 04/25/2024; 07/04/2024; 07/25/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/22/2024; 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2007
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White