MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3543857MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2020
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 manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old hispanic female patient underwent a breast augmentation revision with mentor memorygel, 385cc silicone breast implants which the right side ruptured after implantation.The issue was confirmed by the physician.Silicone rupture noticed during removal surgery.Patient had the device removed on (b)(6) 2020.
Additional Manufacturer Narrative
The below evaluation was mistakenly missed from previous report: the manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.On 3/31/2020, additional information received indicated that there was bilateral implant deformity and symmastia.As a result patient had the deformity and symmastia corrected with inframammary fold repair.And placement of bilateral bella derm grafts; revision mastopexy, and bilateral removal of implants.This report is for the right side.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: during visual inspection of the sample, a tear was observed on the anterior aspect measuring approximately 10.8 cm.As part of our quality process, the manufacturing records of this lot number 7284732 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.Rupture complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing 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 MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9899656
• Report Number: 1645337-2020-05000
• Device Sequence Number: 2596431
• Product Code: FTR
• UDI-Device Identifier: 00081317004431
• UDI-Public: 00081317004431
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2020

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: 01/21/2021
• Device Model Number: 3543857MC
• Device Catalogue Number: 3543857MC
• Device Lot Number: 7284732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 03/31/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/22/2020; 04/23/2020
• 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