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

Catalog Number	3501450
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
The impacted product was received by the failure analysis lab on november 6, 2024.The device, previously unknown, was revealed with receipt of the device, the device is a mentor smooth round spectrum 325cc saline prosthesis, catalog #3501450, lot #5665117.A manufacturing record evaluation was performed for the finished device 5665117 number, and no non-conformances were identified.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.The investigation of the returned device was completed by the failure analysis lab on november 13, 2024.Device evaluation summary: the product was returned to mentor for evaluation, the tubing, the connector, and the injection port were not returned.Mentor conducted a visual inspection, leak testing, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the posterior view measuring approximately 0.2 cm.Microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: deflation.D4: udi: as the catalog/model number was not provided, the (01)gtin is 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.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 who underwent primary breast augmentation with an unknown mentor saline prosthesis experienced right sided deflation post procedure.As a result, replacement with mentor gel boost was performed on (b)(6) 2024.

• 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: 20250621
• Report Number: 1645337-2024-10906
• Device Sequence Number: 7365913
• Product Code: FWM
• UDI-Device Identifier: 00081317001997
• UDI-Public: 00081317001997
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 02/26/2010
• Device Catalogue Number: 3501450
• Device Lot Number: 5665117
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2006
• 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: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White