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

Model Number	3545957MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 64-year-old caucasian female patient underwent a breast reconstruction primary with a mentor memorygel, 595cc silicone breast implant experienced bilateral silent ruptures post procedure.The issue was diagnosed through ultrasound examination.As a result, patient underwent bilateral replacements as follow: left catalog number 3545957, serial number (b)(4), right catalog 354-2557, serial number (b)(4) on (b)(6) 2023.This report relates to the left prosthesis.
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: silent ruptures.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on march 30 , 2023: the product was returned to mentor for evaluation.Mentor conducted a visual inspection.Visual analysis of the returned sample revealed that the sx mod classic gel, 595cc breast implant was found to have a tear on the anterior view, measuring approximately 4.6 cm.As the authorization form for examination was not received the product evaluation lab couldn´t identify a conclusion due to the specific nature of this rupture.The evaluation was limited to non-destructive testing.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause the implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.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
• 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: 16619712
• Report Number: 1645337-2023-03492
• Device Sequence Number: 20612501
• Product Code: FTR
• UDI-Device Identifier: 00081317004516
• UDI-Public: 00081317004516
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 3545957MC
• Device Catalogue Number: 3545957MC
• Device Lot Number: 6462508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2011
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female