MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed deflated.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.Reason for device explant and/or reoperation: deflation manufacturer¿s reference number:pc-(b)(4).
Event or Problem Description
It was reported that a female patient who underwent primary breast augmentation surgery with two 125cc mentor smooth round moderate profile saline breast implants experienced bilateral deflation post procedure.As a result, patient had an explantation on an unspecified date.This medwatch form is for the breast prosthesis b.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on may 22, 2022.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the sal smooth rnd diap 125cc breast implant was found to have a tear extending from the anterior view to the posterior view, measuring approximately 5.3 cm within a missing material on the posterior view measuring approximately 0.1 x 0.1 cm.Microscopic examination was performed on the edges of the tear and the missing material, and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear and the missing material, and the thickness was within manufacturing specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 26, 2022, 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.Patient's initials are (b)(6).Patient's explantation date is on (b)(6) 2022.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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 ; 6465917981
• MDR Report Key: 14055979
• Report Number: 1645337-2022-03949
• Device Sequence Number: 4987347
• Product Code: FWM
• UDI-Device Identifier: 00081317001171
• UDI-Public: 00081317001171
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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: 02/13/2012
• Device Model Number: 3501610
• Device Catalogue Number: 3501610
• Device Lot Number: 5803326
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 05/22/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/18/2022; 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2008
• 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