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

Model Number	3341404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wrinkling (2613)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 (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.Reason for device explant and/or reoperation: n/a.Note: the patient is participating in glow study : mnt-men-15-003: 326-077 manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a breast reconstruction with a mentor memoryshape breast implant 680cc and suffered from a cutaneous contour deformity on the left side.On (b)(6) 2020, she presented with wrinkling, which required surgical intervention: fat grafting on (b)(6) 2020.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
After clinical/secondary review of this file performed on (b)(6) 2021, it was decided to add code surgical intervention to more accurately capture the reported event.Manufacturer¿s reference number: (b)(4) after clinical/secondary review of this file performed on (b)(6) 2021, it was decided to add code surgical intervention to more accurately capture the reported event.

• Brand Name: MENTOR MEMORYSHAPE 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: 12029060
• Report Number: 1645337-2021-06963
• Device Sequence Number: 14267815
• Product Code: FTR
• UDI-Device Identifier: 00081317024262
• UDI-Public: 00081317024262
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2023
• Device Model Number: 3341404
• Device Catalogue Number: 3341404
• Device Lot Number: 7586397
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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: Other
• Patient Weight: 68