MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SMHX310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.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.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 will be conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: left rupture.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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 female patient underwent revision breast augmentation with 310cc mentor memorygel xtra breast implant and experienced breast implant rupture on her left side postoperatively.As a result, the patient underwent left side replacement surgery with catalog number smhx310; serial number: (b)(6) on (b)(6) 2025.
Additional Manufacturer Narrative
On february 5, 2026, device evaluation was completed as follows: mentor conducted a visual inspection, microscopic examination, and shell thickness of the returned device.Visual analysis of the returned device revealed that the breast implant was found to be ruptured.Microscopic examination was performed, and the cause of the tear could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.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.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation but is more likely to occur the longer the implant is implanted.The following may cause implant to rupture: stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.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).
Additional Manufacturer Narrative
On january 16, 2026, 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.Per paperwork received with the device, following information was received: - patient's initials under field a1 has been updated to "(b)(6)".- patient's date of birth was provided as (b)(6) 1997; field a2 has been updated to "(b)(6) 1997".Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 23706994
• Report Number: 1645337-2025-13414
• Device Sequence Number: 10628832
• Product Code: FTR
• UDI-Device Identifier: 10081317027826
• UDI-Public: 10081317027826
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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: SMHX310
• Device Lot Number: 9957546
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/05/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/02/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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: 28 YR
• Patient Sex: Female