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	02/12/2018
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 products: 275cc mentor siltex round spectrum post-operatively adjustable saline breast implant, catalog #3542440m, lot #144599.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old (b)(6) female underwent primary breast augmentation with a 275cc mentor siltex round spectrum post-operatively adjustable saline breast implant.Deflation was diagnosed on (b)(6) 2018 through a physician¿s examination on (b)(6) 2018.As a result, bilateral prosthesis replacement was performed on (b)(6) 2018.
Additional Manufacturer Narrative
The device history record (dhr) of lot number 144599 was reviewed on 5/16/2018 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 6/26/2018.Device evaluation summary: it was reported that a (b)(6)-year-old caucasian female underwent primary breast augmentation with a 275cc mentor siltex round spectrum post-operatively adjustable saline breast implant.Deflation was diagnosed on (b)(6)2018 through a physician¿s examination on (b)(6)2018.Upon receipt by mentor, the device returned without fluid.White material was observed within the device and on the shell surface.Upon visual examination, the device appears intact.No other anomalies were discovered.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the product evaluation team was precluded from further evaluating the device.The complaint was not confirmed.There is no evidence that the issue is related with manufacturing.Because the product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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: 7340180
• Report Number: 1645337-2018-01482
• Device Sequence Number: 187565
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• 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: 1997
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2018

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: 03/31/2001
• Device Catalogue Number: 3542440M
• Device Lot Number: 144599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018; 02/14/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 06/05/2018; 06/28/2018
• 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: 45 YR