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

Model Number	3501485
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/16/2019
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 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 (b)(6) female patient who underwent breast reconstruction with a 525cc mentor smooth round spectrum saline breast prosthesis on the right breast, suffered right breast implant deflation post-operatively.As a result, the patient underwent implant explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2020, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 2/12/2020, the product investigation was completed.A manufacturing record evaluation (mre) was performed for the complaint device.The manufacturing record evaluation (mre) was reviewed, 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.Device investigation summary: during visual inspection of the device, the shell was observed with no apparent damage.Device was received with tubing detached from the injection reservoir.Leak testing revealed a missing material in the posterior aspect measuring approximately 0.1 x 0.1 cm.Microscopic examination of the edges of the rupture revealed parallel striations consistent with a rupture with a sharp object.The striations are consistent with markings made by a sharp instrument perforating silicone material.As stated in the product insert data sheet, do not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures as this can result in rupture.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 9560054
• Report Number: 1645337-2020-00415
• Device Sequence Number: 14024215
• Product Code: FWM
• UDI-Device Identifier: 00081317002031
• UDI-Public: 00081317002031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2019

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: 11/30/2022
• Device Model Number: 3501485
• Device Catalogue Number: 3501485
• Device Lot Number: 7646313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/11/2020; 02/12/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/15/2020; 02/13/2020
• 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: 45 YR