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

Model Number	3542470M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: mentor conducted visual inspection, leak testing, and microscopic examination of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the spec siltex rnd 425cc returned device.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the posterior view, measuring approximately 0.1 cm.Microscopic examination was performed and instrument damage was not found on the area of the tear.The paperwork received specifies that the breast implant was punctured intentionally to deflate, however, after microscopic examination, both devices were analyzed since instrument damage was not found.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.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 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 63-year-old non hispanic/latino female patient underwent revision breast augmentation with a 425cc mentor siltex round spectrum on both sides and experienced breast implant deflation on her right side postoperatively.On (b)(6) 2023, mentor became aware that the replacement devices used on (b)(6) 2023 were serial numbers (b)(4) on the left side, and (b)(4) on the right side.On (b)(6) 2023, the mentor failure analysis lab received two device for evaluation.Paperwork received with the device indicated that the replacement surgery was on (b)(6)2023.On (b)(6) 2023, the mentor failure analysis lab completed preliminary analysis of the devices received which were found damaged since both products received had the same volume engraved, it could not be determined which device is the suspect medical device for the reported rupture.Hence, this report is being submitted for the patient¿s second ruptured (left-sided) device.This medwatch report is for the patient¿s left-sided device.

• Brand Name: MENTOR SILTEX 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: 16659765
• Report Number: 1645337-2023-03797
• Device Sequence Number: 16569089
• Product Code: FWM
• UDI-Device Identifier: 00081317002116
• UDI-Public: 00081317002116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 10/31/1998
• Device Model Number: 3542470M
• Device Catalogue Number: 3542470M
• Device Lot Number: 86080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/1993
• 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: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White