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

Model Number	3542480M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch report was initially submitted on september 22, 2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket (b)(4) for additional details.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: no information regarding explantation or an expected explantation date has been received.(b)(4).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 67-year-old female patient underwent a breast augmentation revision with two unspecified saline breast prostheses and experienced generalized illness symptoms including allergies, breast implant illness, anxiety, pain, headaches, feels irritable, just feels different, depression, and stating she does not feel like herself anymore post-operatively.It was also reported that the patient had bilateral deflation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It was unknown if the reported device was a mentor device and as such the complaint is being reported conservatively.If more information becomes available, mentor will submit a supplemental report accordingly.This report is for the left side device.
Additional Manufacturer Narrative
On august 16, 2023, a photo evaluation for the device was completed.The date of device explantation is currently unknown.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed deflated.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.At the present time, there is no sufficient evidence to show an association between breast implants and generalized illness (assessing the risks of breast implants and fda¿s vision for the national breast implant registry).It should be noted that as part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, 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 may 19, 2023, mentor received additional information regarding the impacted device and date of implantation.It was reported that the impacted device was a 475cc mentor siltex round spectrum with catalog number 3542480m.The lot number has been updated to 92744.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.The date of implantation has been updated to (b)(6) 1994.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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 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: 15910543
• Report Number: 1645337-2022-11234
• Device Sequence Number: 2519647
• Product Code: FWM
• UDI-Device Identifier: 00081317002123
• UDI-Public: 00081317002123
• 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: 1994
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 04/30/1999
• Device Model Number: 3542480M
• Device Catalogue Number: 3542480M
• Device Lot Number: 92744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 05/19/2023; 06/09/2023; 08/16/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 06/07/2023; 06/28/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/1994
• 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: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female