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

Model Number	SMPX560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a primary breast augmentation with an unspecified gel breast prosthesis and experienced capsular contracture (baker grade 3) on the left side post-operatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It was unknown if the reported device was a mentor device and as such the complaint is being reported conservatively.If more information becomes available, mentor will submit a supplemental report accordingly.
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: no information regarding explantation or an expected explantation date has been received.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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
On june 112, 2023, mentor received additional information regarding the patient, date of event, device, and capsular contracture's baker grade the patient's initials were updated to (b)(6).The patient's date of birth was updated to (b)(6) 1983.The device date of implantation was updated to (b)(6) 2021.The capsular contracture's baker grade was reported to be baker grade 4.The date of event was updated to december 02, 2021.The lot number was updated to 9513788.The serial number was updated to (b)(6).A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.All relevant fields have been updated to reflect the additional information received.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 16869572
• Report Number: 1645337-2023-05262
• Device Sequence Number: 14904407
• Product Code: FTR
• UDI-Device Identifier: 00081317025122
• UDI-Public: 00081317025122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 11/01/2025
• Device Model Number: SMPX560
• Device Catalogue Number: SMPX560
• Device Lot Number: 9513788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/05/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/05/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female