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

Catalog Number	3542515
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a primary breast reconstruction with a 425cc mentor smooth round moderate profile saline breast prosthesis and experienced deflation on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2023.A discrepancy was observed when the information reported included a date of implantation that occurred prior to the manufacturing date of the breast implant.As this is not possible, mentor associates will reach out for further information.If new information becomes available, mentor will submit a supplemental report.
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: deflation.Section d6a.Device implantation date reported: (b)(6) 2019.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 october 20, 2023, the mentor failure analysis lab has 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.It was determined that the impacted device was a 650cc mentor siltex contour profile spectrum saline breast prosthesis with catalog number 3542515 and lot number 7420556.A manufacturing record evaluation for lot number 7420556 is in progress.Once completed, a supplemental report will be submitted.All relevant fields have been updated on this report to reflect this additional information.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 21, 2023, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned sample revealed that the spec siltex contour 650cc breast implant have a tear on the posterior view within an area of siltex cracking, measuring approximately 0.6 cm.A microscopic examination was performed and no instrument damage was observed at the edges of the rupture.The evaluation determined that the possible cause of the deflation is 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE 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: 17932671
• Report Number: 1645337-2023-12182
• Device Sequence Number: 6352075
• Product Code: FWM
• UDI-Device Identifier: 00081317002178
• UDI-Public: 00081317002178
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 01/15/2021
• Device Catalogue Number: 3542515
• Device Lot Number: 7420556
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: Not provided; 11/21/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/08/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2017
• 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 Sex: Female