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
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: right deflation.Explantation date: (b)(6) 2023.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 and experienced breast implant deflation on her right side postoperatively.As a result, the patient is scheduled for replacement surgery on (b)(6) 2023.
Additional Manufacturer Narrative
On march 27, 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.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.This supplemental medwatch report is for the patient¿s right-sided device.Left side device found damaged is being reported separately.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 29, 2023, device evaluation was completed.Device evaluation summary: mentor conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the spec siltex rnd 425cc breast implant had an area of siltex cracking on the posterior view.In addition, a tear was noted within the siltex cracking measuring approximately 0.2 cm.A microscopic examination was performed and instrument damage was not found on the area of the tear.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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 24, 2022, the following information has been updated on this form: patient is caucasian.Date of even was (b)(6) 2022; serial number (b)(6).Date of explant is (b)(6) 2023 manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 23, 2023, mentor became aware that the replacement devices used on (b)(6), 2023 were serial numbers (b)(6) on the left side, and (b)(6) on the right side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 30, 2023, mentor became aware that the date of surgery was moved to (b)(6) 2023.Field d6b has been updated on this form.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 28, 2023, the mentor failure analysis lab 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.Paperwork received with the device indicated that the replacement surgery was on (b)(6) 2023.Field d6b has been updated on this form.Manufacturer¿s reference number: (b)(4).

• 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: 15621154
• Report Number: 1645337-2022-12445
• Device Sequence Number: 6470575
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 12/31/2002
• Device Model Number: 3542470M
• Device Catalogue Number: 3542470M
• Device Lot Number: 167778
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 01/30/2023; 02/23/2023; 02/28/2023; 03/29/2023; 03/27/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/02/2022; 02/01/2023; 02/27/2023; 03/20/2023; 03/29/2023; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/1997
• 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