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

Model Number	3542615
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent primary breast augmentation with 150cc saline mentor siltex round moderate profile breast implants and experienced deflation on the right side postoperatively.As a result, the patient underwent device removal and replacement with an unspecified saline mentor breast implant on (b)(6) 2020.
Additional Manufacturer Narrative
Additional information: on may 28, 2020, the mentor failure analysis lab received the device for evaluation.On may 28, 2020, mentor became aware that the patient underwent device removal on (b)(6) 2020.On june 3, 2020, the product investigation was completed.Device investigation summary: during the visual evaluation of the device, an area of siltex cracking was observed on the posterior aspect.Additionally, it was revealed a tear within the siltex cracking measuring approximately 0.3cm.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stress.As part of our quality process, the manufacturing records of this 213525 lot number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: on march 25, 2020, 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).
Additional Manufacturer Narrative
Additional information: on march 30, 2020, mentor became aware that patient's device removal procedure has been put on hold due to covid-19.Manufacturer's reference number: (b)(4).

• 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: 9789047
• Report Number: 1645337-2020-03640
• Device Sequence Number: 13593064
• Product Code: FWM
• UDI-Device Identifier: 00081317001720
• UDI-Public: 00081317001720
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2020

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 Expiration Date: 06/30/2004
• Device Model Number: 3542615
• Device Catalogue Number: 3542615
• Device Lot Number: 213525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 03/30/2020; 05/28/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/26/2020; 04/08/2020; 06/16/2020
• 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: 50 YR