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

Catalog Number	3507190MC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a during a scheduled breast augmentation procedure, a mentor memorygel breast implant 190cc gel breast prosthesis that was noted to be defective.It was reported that the center of the round bottom patch is excessively protruded.There was no reported patient consequence.
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: n/a.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
On 01-aug-2024, mentor completed the investigation on the suspect medical device.The investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Device evaluation summary: according to the information received, the center of the round bottom patch is excessively protruded.During visual evaluation of the image provided, some bubbles were observed in the gel.However, the patch looks normal.As the product involved in this complaint was not received, the device couldn't be analyzed according to our procedures.Bubbles in the gel can be originated with changes in pressure and temperature which can affect volume.The shell wall is permeable to air, therefore trapped air can form bubbles with changes in pressure or temperature.When left by themselves with no changes in temperature or pressure, bubbles usually dissipate over time, unless trapped by cured gel.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances 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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.H6 investigation findings c22: cosmetic defect manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 17-sep-2024, the mentor failure analysis lab 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 17-oct-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, bubbles were observed in the breast implant during surgery, and the center of the round button patch is excessively protruded.The product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to have some bubbles within the gel.Also, no anomalies were observed in the button of the patch.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.Bubbles in the gel can originate with changes in pressure and temperature which can affect volume.The shell wall is permeable to air, therefore trapped air can form bubbles with changes in pressure or temperature.When left by themselves with no changes in temperature or pressure, bubbles usually dissipate over time, unless trapped by cured gel.The issue in the button of the patch could not be confirmed since the variation in the height of the button center of the patch is a normal condition that can occur in the manufacturing process and this should not impact the functionality of the device.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 is conducted through complaint trending as part of post-market surveillance.H6 investigation findings c22: cosmetic defect.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: 19742744
• Report Number: 1645337-2024-08358
• Device Sequence Number: 3641128
• Product Code: FTR
• UDI-Device Identifier: 00081317004097
• UDI-Public: (01)00081317004097(11)231205(17)281202(10)9982385
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3507190MC
• Device Lot Number: 9982385
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024; 09/17/2024; 10/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/07/2024; 10/01/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown