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

Catalog Number	3542630
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/15/2024
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.Reason for device explant and/or reoperation: right deflation.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D6b explantation date: on (b)(6) 2025.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 65-year-old caucasian female patient underwent revision breast augmentation with 225cc mentor siltex round moderate profile and experienced breast implant deflation on her right side postoperatively; diagnosed in the office.The patient has consulted with the healthcare professional.As a result, the patient is scheduled for surgery on (b)(6) 2025.
Additional Manufacturer Narrative
On january 27, 2025, mentor became aware that the replacement devices used on (b)(6), 2025 were catalog number 3503254; serial number (b)(6) on the left side, and catalog number 3503254; serial number (b)(6) on the right side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 13, 2025, the mentor failure analysis lab received the device for evaluation.On february 20, 2025, device evaluation was completed as follows: mentor conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the breast implant had a tear on the posterior view, measuring approximately less than 0.1 cm.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.Because of the now settled u.S.Class action that applied, in part, to implants manufactured in texas, usa that were released to finished goods before april 1, 1984, to avoid any potential allegation of spoliation of evidence, mentor is prohibited from conducting a further physical evaluation of this covered device.Mentor performs 100% inspection of all devices prior to release, product evaluation concluded that the tear occurred sometime subsequent to the removal of the device from its protective packaging.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.The contralateral device was also received.The patient did not report any issues with this device.Therefore, no further analysis of the contralateral device is required.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• 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: 21194383
• Report Number: 1645337-2025-00191
• Device Sequence Number: 20914286
• Product Code: FWM
• UDI-Device Identifier: 00081317001751
• UDI-Public: 00081317001751
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: 3542630
• Device Lot Number: 88524
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/27/2025; 02/13/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 01/27/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/1993
• 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: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White