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

Catalog Number	SHPB405
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 405cc mentor memorygel boost breast implant was identified to have smears and unspecified type of material on its shell, pre-implantation.No adverse event was experienced by the patient.The surgeon used backup devices, and there were no reported patient consequences or procedural delays.
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: 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).
Additional Manufacturer Narrative
On july 11, 2025, an analysis of the suspect medical device¿s photo was completed.Investigation summary: during visual evaluation of the image provided, some brownish material was observed adhered to the shell of the implant.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 Manufacturer Narrative
On october 3, 2025, 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.Mentor also received additional information indicating that the date of event was on june 12, 2025.
Additional Manufacturer Narrative
On february 27, 2026, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and material evaluation of the returned device.Visual analysis of the returned device determined that a yellow particle was observed over the shell on the anterior view, the particle was measured with a calibrated tappi chart and the size was 0.6 mm² (0.006 cm²).In addition, the device was received without the thermoform.The chemical composition of the yellow spot found in the silicone implant results revealed that foreign material exhibited the chemical composition for unsaturated polyester resin base material.However, the exact source of origin cannot be determined.The identification and characterization of the yellow spot observed was compared to an existing toxicology report.The assessment concluded that the identified material, will not alter the biocompatibility profile of the finished product.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.The mentor microbiology department provided the device's sterility assurance records.The lot met all the sterilization parameters required to provide sterility assurance before release for distribution.In conclusion, per documentation reviewed, the manufacturing of device followed normal process and met specifications throughout the different process controls included in the process.Though not confirmed, there is a possibility that the particle/foreign matter found in the device be related to the knitted wipe.Nevertheless, the size of the particle/foreign matter is within the acceptable passing criteria.Therefore, product complaint is considered manufacturing related within process specifications.

• Brand Name: MENTOR MEMORYGEL BOOST 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: 22408703
• Report Number: 1645337-2025-07397
• Device Sequence Number: 9664764
• Product Code: FTR
• UDI-Device Identifier: 00081317027065
• UDI-Public: (01)00081317027065(17)291109(10)2006281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SHPB405
• Device Lot Number: 2006281
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 10/03/2025; 02/27/2026
• Initial Report FDA Received Date: 07/06/2025
• Supplement Report FDA Received Date: 07/30/2025; 10/17/2025; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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
• Patient Sex: Unknown