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

Model Number	3542620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/01/2020
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: right breast prosthesis deflation.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation revision procedure with a mentor siltex round moderate profile 175cc saline breast prosthesis that deflated after implantation.Deflation of the patient¿s right breast prosthesis was diagnosed by a physical exam.As a result, the patient is scheduled to undergo bilateral explantation and replacement with unspecified breast prostheses on (b)(6) 2020.

• 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
• MDR Report Key: 10681364
• Report Number: 1645337-2020-13077
• Device Sequence Number: 18908053
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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 Model Number: 3542620
• Device Catalogue Number: 3542620
• Device Lot Number: 128079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: 73 YR