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

Model Number	3541507
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 74-year-old caucasian female who underwent an unspecified breast augmentation with an mentor memorygel, 150cc breast implant experienced right sided silent rupture postoperatively.The ct scan confirmed the issue.As a result, patient underwent bilateral replacements with unspecified mentor silicone implants on (b)(6) 2022.This is related to adjunct study.
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: rupture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on (b)(6) 2022 indicated that the patient had to postpone her surgery until (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on october 6, 2022 indicated that date of removal rescheduled to (b)(6) 2022.Manufacturer¿s reference number: (b)(4).Investigation summary according to the information received, the patient experienced a rupture in the breast implant.The ruptured breast implant involved in this complaint was not received.Therefore, your device couldn´t be analyzed according to our procedures.Please ship the product back to us to receive a more detailed analysis about your product complaint.If you have recently shipped the product back, please provide your tracking numbers by replying to this email.If you need additional support to return the ruptured device, please contact our team using the information contained at the end of this letter.Although the product was not received, the manufacturing records of the lot-serial number were reviewed.The manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Rupture complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.Device history lot a manufacturing record evaluation was performed for the finished device 204955 number, and no non-conformances were identified.Manufacturing date: jan-2000.Expiration date: jan-2005.Device history batch = > null.Device history review = > null.
Additional Manufacturer Narrative
Suspect device received on november 21, 2022.Device evaluation completed on november 24 , 2022: 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 gel siltex mod-rnd 150cc breast implant had an area of siltex cracking on the posterior view.In addition, a tear was noticed within the siltex cracking, measuring approximately 1.2 cm.The evaluation determined that the 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.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14496337
• Report Number: 1645337-2022-06056
• Device Sequence Number: 6018972
• Product Code: FTR
• UDI-Device Identifier: 00081317000617
• UDI-Public: 00081317000617
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 01/31/2005
• Device Model Number: 3541507
• Device Catalogue Number: 3541507
• Device Lot Number: 204955
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 10/06/2022; 11/21/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/06/2022; 10/12/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2000
• 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: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White