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

Catalog Number	3501430
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor asr reference number (b)(4).Device evaluation summary: upon receipt at mentor, the device contained no fluid.White material was observed within the device and no foreign material was observed on the shell surface.During examination, the product evaluation team observed creases on both aspects.A rent was found measuring approximately <0.1cm within the crease on the posterior aspect.No other anomalies were observed.Mentor performs 100% inspection and testing of all devices prior to release, and as a result, pe concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.A root cause of the failure could not be determined.Breast implants are not considered lifetime devices, and deflation is a known complication associated with these devices as referenced in our product insert data sheet.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.(b)(4).
Event or Problem Description
This report contains supplemental information for mentor asr reference number (b)(4).On (b)(6) 2019, mentor confirmed that asr submission reference numbers (b)(4) were duplicated.This file has been updated to contain all of the most current and correct information, and final reporting/documentation of this event will take place in this complaint file, manufacturer's reference number (b)(4).It was reported that a (b)(6)-year-old caucasian female patient underwent an unspecified breast surgery with a mentor 225cc smooth round spectrum saline breast implant that deflated postoperatively.As a result, the patient had the device explanted and replaced with an unspecified implant on (b)(6) 2017.
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 SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8956431
• Report Number: 1645337-2019-18291
• Device Sequence Number: 2087764
• Product Code: FWM
• UDI-Device Identifier: 00081317001973
• UDI-Public: 00081317001973
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 03/28/2010
• Device Catalogue Number: 3501430
• Device Lot Number: 5672541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 54 YR