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

Catalog Number	3501480
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/07/2025
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: breast prosthesis deflation.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 a breast augmentation revision procedure with a mentor smooth round spectrum 475cc saline breast prosthesis that deflated post implantation.Deflation of the patient¿s right breast prosthesis was diagnosed during an office visit.As a result, the patient underwent explantation on (b)(6) 2025.
Additional Manufacturer Narrative
On 05-mar-2025, the mentor failure analysis lab received the device for evaluation.On 06-mar-2025, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the breast implant.The product was returned to mentor for evaluation with approximately 26.0 cm of tubing attached to the implant, the connector and injection dome were not returned.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the breast implant.The tube was examined, and an indentation was noted on the proximal end of the fill tube, most likely from where the suture was tied to the injection dome connector.Leak testing was performed, according to the mentor procedure, and it was noted that the valve plug was still connected to the tube inside the implant and not seated on the valve.Therefore, the valve and implant remained in an open position, allowing the solution to flow out of the device.The tubing was removed from the valve, and the product worked as expected.The tubing broke off correctly, and the valve plug was properly seated on the valve, closing the device.An additional leak test was performed, and no leaks were detected.The product insert data sheet states that when removing the injection dome and fill tube, the tube needs to be grasped beyond the connector, and it should be removed before taking out the injection dome.Do not pull on the connector while removing the tube, as this may cause it to disconnect, which could lead to subsequent deflation.Use slow and steady traction to remove the fill tube to prevent damage to the prosthesis or its self-sealing valve.Continue to pull firmly on the fill tube until its entire length is withdrawn, which will be indicated by a notch at the end of the tube.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 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 08-apr-2025, mentor received additional information about the event.The patient¿s explanted breast prosthesis was replaced with a mentor smooth round spectrum 475cc saline breast 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: 21203869
• Report Number: 1645337-2025-00543
• Device Sequence Number: 18162736
• Product Code: FWM
• UDI-Device Identifier: 00081317002024
• UDI-Public: (01)00081317002024(17)260113(10)9677903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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 Expiration Date: 01/13/2026
• Device Catalogue Number: 3501480
• Device Lot Number: 9677903
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 04/08/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: 45 YR
• Patient Sex: Female