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

Catalog Number	3542635
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
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 is in progress.  once completed, a supplemental report will be submitted.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.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 250cc mentor siltex round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated right breast implant during a physical exam with a medical professional.As a result, the patient underwent breast implant removal on (b)(6) 2024.
Additional Manufacturer Narrative
On june 06, 2024, mentor was notified that the patient's explantation surgery was rescheduled for (b)(6) 2024.On june 10, 2024, 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.Date of explantation: (b)(6) 2024.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 20, 2024, mentor was notified that the explantation surgery was performed on (b)(6) 2024.On june 21, 2024, mentor became aware that the patient underwent bilateral removal and replacement with 325cc mentor smooth round moderate plus profile saline breast implants during the surgery.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 24, 2024, mentor became aware that information was inadvertently omitted from the second supplemental report.Corrected data: in the supplemental report, h6 health effect - clinical code should have included no clinical signs, symptoms or conditions (e2403) as a mammogram imaging report indicated there was simple fluid surrounding the implant membrane.H6 health effect - clinical code: no clinical signs, symptoms or conditions (e2403).On july 03, 2024, the mentor analysis lab received the suspect medical device for evaluation.On july 04, 2024, mentor completed an evaluation on the returned device.Mentor conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant had an area of missing material on the anterior view, measuring approximately 5 cm x 3 cm.In addition, siltex cracking was observed at the edges of the missing material.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.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19443209
• Report Number: 1645337-2024-06560
• Device Sequence Number: 20968670
• Product Code: FWM
• UDI-Device Identifier: 00081317001768
• UDI-Public: 00081317001768
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1995
• 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,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: 08/31/2003
• Device Catalogue Number: 3542635
• Device Lot Number: 124611
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 06/20/2024; 06/24/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 06/17/2024; 06/21/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/1995
• 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: 48 YR
• Patient Sex: Female