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

Catalog Number	3542757MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent an unspecified breast augmentation with a mentor memorygel, 275cc on the left, and 300cc on the right side, silicone prosthesis experienced bilateral silent rupture post procedure.As a result, patient underwent bilateral replacements with unknown implants on an unspecified date.This report relates to the left side.
Additional Manufacturer Narrative
Devices photo evaluation completed on december 12 , 2023 upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.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.Reason for device explant and/or reoperation: silent rupture 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
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.Per additional information received with the device, patient underwent bilateral replacements as follow: r/ cat: smpx325, sn: (b)(6), l/ smpx295, sn: (b)(6) on (b)(6) 2023, procedure status updated to primary breast augmentation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on (b)(6) 2024.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sx mod classic gel, 275cc breast implant had a tear within an area of siltex cracking on the posterior view, measuring approximately 0.1 cm.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4) follow up;(1) mistakenly reported incorrect procedure.Correction: procedure: breast augmentation revision.

• 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: 18427023
• Report Number: 1645337-2024-00013
• Device Sequence Number: 7730988
• Product Code: FTR
• UDI-Device Identifier: 00081317004387
• UDI-Public: 00081317004387
• 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 Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 3542757MC
• Device Lot Number: 6746128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 02/13/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/29/2024; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2013
• 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 Sex: Female