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

Catalog Number	3542440M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant medical products: saline mentor siltex round spectrum 275cc breast implant, catalog number 3542440m, lot number 5637436, serial number (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast reconstruction primary procedure with saline mentor siltex round spectrum 275cc breast implants and experienced bilateral deflation.The deflation was diagnosed by the healthcare professional by the mammogram on (b)(6) 2017.As a result, the patient had undergone removal and replacement on (b)(6) 2018.This medwatch is for the left breast implant.
Additional Manufacturer Narrative
On 04/20/2018, it was reported to mentor that the device history record ( dhr) of lot number 5637436 reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.On 04/26/18, it was reported to mentor that device evaluation and investigation have been completed.Upon device were received without fluid.Foreign material wasn¿t observed within device and white material on shell surface.Device appears intact.No anomalies were discovered.Complaint was not confirmed.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, product evaluation team was precluded from further evaluating the device.Mentor performs 100% inspection and testing of all devices prior to release.A root cause failure analysis will not be conducted since the investigation of the reported failure could not confirm that an actual failure of the device to conform to expected performance had occurred.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.Because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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
• MDR Report Key: 7412661
• Report Number: 1645337-2018-01862
• Device Sequence Number: 13862263
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 10/31/2009
• Device Catalogue Number: 3542440M
• Device Lot Number: 5637436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: 52 YR