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

Catalog Number	3545375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
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 for lots 9950540 and 9984734, 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.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined with the available information.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.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 375cc mentor memorygel breast implant prosthesis ruptured during a breast surgery prior to being implanted into the patient.However, the surgery commenced without any reported delays and a new implant was used to complete the implantation.No adverse events or patient consequences were reported.As the affected device was not provided, the lot/serial numbers for both products are being provided as device a - lot number: 9950540 / serial number: (b)(6) and device b - lot number: 9984734 / serial number: (b)(6).Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On september 24, 2024, the mentor analysis lab received two devices for evaluation.On september 30, 2024, mentor completed evaluations on the returned devices.The identity of the ruptured suspect medical device was determined as the following: lot: 9950540.Serial: (b)(6).Mentor conducted a visual inspection and microscopic examination of the device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured.Microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: according to the product insert data sheet, it is possible to damage the implant during insertion.Ensure that excessive force is not applied to a very small area of the shell during insertion of the device through the incision.Instead, apply force over as large an area of the implant as possible.Avoid pushing the device into place with one or two fingers in a localized area, as this may create an area of weakness on the shell.In addition, an incision should be of appropriate length to accommodate the style, size, and profile of the implant.This will reduce the potential for creating excessive stress to the implant during insertion, and will avoid the risk of damage to the implant.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: 20018838
• Report Number: 1645337-2024-09763
• Device Sequence Number: 8748053
• Product Code: FTR
• UDI-Device Identifier: 00081317007135
• UDI-Public: (01)00081317007135(17)280826(10)9950540
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3545375
• Device Lot Number: 9950540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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
• Patient Sex: Unknown