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

Model Number	3542625
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reason for device explant and/or reoperation: 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.Suspect device received on (b)(6) 2022.Device evaluation completed on (b)(6) 2022: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sal siltex rnd diap pkg 200cc breast implant.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the posterior view within the siltex cracking, measuring approximately 0.2 cm.The evaluation determined that the cause of the deflation was consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.It should be noted that as part of the mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 221480 number, and no non-conformances were identified.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 54-year-old caucasian female who underwent a breast augmentation primary with a mentor siltex round moderate profile, 200cc saline breast implant, experienced left-sided silent deflation post procedure.The issue was discovered during office visitation.As a result, patient underwent bilateral replacements with cat#: smpx-270 on (b)(6) 2022.
Additional Manufacturer Narrative
Additional information received on january 15, 2023 indicated that the replacement devices are as follow: sn#: (b)(6), cat#:smpb265 smo ro mod pro boost gel 265cc, sn#: (b)(6), cat#: smpb265 smo ro mod pro boost gel 265cc.Sides were not reported.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on january 20, 2023 indicated the sides of the replacement devices: sn#:(b)(6) cat#:smpb265 smo ro mod pro boost gel 265cc ¿ implanted left sn#:(b)(6) cat#:smpb265 smo ro mod pro boost gel 265cc ¿ implanted right manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14842883
• Report Number: 1645337-2022-07529
• Device Sequence Number: 2367113
• Product Code: FWM
• UDI-Device Identifier: 00081317001744
• UDI-Public: 00081317001744
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2022
• 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: 12/01/2004
• Device Model Number: 3542625
• Device Catalogue Number: 3542625
• Device Lot Number: 221480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 01/02/2023; 01/20/2023
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 01/19/2023; 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2000
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White