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

Model Number	3542511
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2020
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: breast pain, deflation.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with a 275cc mentor siltex contour profile spectrum prosthesis (right) and a 275cc mentor siltex contour profile high prosthesis (left) and experienced bilateral deflation, left-sided paresthesia, and right-sided breast pain postoperatively.Initially, the patient reached out to mentor stating that she experienced right-sided deflation and left-sided nerve damage.The patient had a consultation with her physician and stated that she experienced right-sided deflation and breast pain/discomfort.In addition, the patient¿s physician noted that she had a history of the left breast implant with subsequent surgical treatment.As a result, the patient underwent explantation on (b)(6) 2020.At this time of report, the date of explantation for the left-sided device is unknown and is estimated as (b)(6) 2020 based on available information.Follow-up is still in progress.If additional information is received in the future, a supplemental report will be submitted.This report is for the right-sided prosthesis.
Additional Manufacturer Narrative
On 14-jan-2020, mentor received additional information regarding the date of explantation.The date of explantation was rescheduled from (b)(6) 2020, to (b)(6) 2021.However, the patient also stated that her surgeon is no longer available, and she will need to find a new surgeon for the revision surgery.The relevant field has been updated.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
• MDR Report Key: 10945560
• Report Number: 1645337-2020-15331
• Device Sequence Number: 11483528
• Product Code: FWM
• UDI-Device Identifier: 00081317002130
• UDI-Public: 00081317002130
• 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: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 07/20/2013
• Device Model Number: 3542511
• Device Catalogue Number: 3542511
• Device Lot Number: 5924574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR