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

Catalog Number	3542460M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	07/09/2019
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: capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent primary breast reconstruction with a (left) 250cc mentor siltex round moderate profile saline and a (right) 375cc mentor siltex round spectrum saline breast prostheses, suffered left side deflation and right side capsular contracture; baker grade iii, post-operatively.As a result, the patient underwent bilateral removal and replacement with the following devices on (b)(6) 2019: (left) 300cc mentor smooth round moderate plus profile saline catalog: 3502300 lot: 7328209 sn: (b)(4) and (right) 475cc mentor smooth round moderate plus profile saline catalog: 3502475 lot: 7716786 sn: (b)(4).This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On 10/3/2019, mentor became aware that the capsular contracture that the patient experienced was actually baker grade iv.Manufacturer¿s reference number: (b)(4).This medwatch form is for the right breast prosthesis.

• 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
• MDR Report Key: 8967779
• Report Number: 1645337-2019-18633
• Device Sequence Number: 19370753
• Product Code: FWM
• UDI-Device Identifier: 00081317002109
• UDI-Public: 00081317002109
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2014
• Device Catalogue Number: 3542460M
• Device Lot Number: 5979838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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: 73 YR