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

Model Number	TMPX295
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/16/2021
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 (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: patient dissatisfaction with procedure outcome.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent breast surgery with a 295cc mentor memorygel xtra breast implant experienced dissatisfaction of implant on an unspecified side post procedure.As a result, patient had an explantation on (b)(6) 2021.
Additional Manufacturer Narrative
On (b)(6) 2021 the mentor failure analysis lab has received the device for evaluation.The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2021.Device evaluation summary: according to the information received, the patient dislikes the product.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the siltex mod+prof xtra 295cc returned device.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021 the mentor failure analysis lab has received a photo of the device for evaluation.The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2021.Device evaluation summary: according to the information received, the patient dislikes the product.Upon visual evaluation of the image provided in the complaint, the implant was observed intact.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA 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: 12059617
• Report Number: 1645337-2021-07179
• Device Sequence Number: 4110807
• Product Code: FTR
• UDI-Device Identifier: 00081317025450
• UDI-Public: 00081317025450
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2021

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: 07/10/2023
• Device Model Number: TMPX295
• Device Catalogue Number: TMPX295
• Device Lot Number: 7580703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/27/2021; 07/16/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 06/28/2021; 08/10/2021
• 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: Required Intervention