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	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 73-year-old female patient who underwent breast patient surgery with a 125cc mentor smooth round moderate profile saline breast implant experienced right sided deflation post procedure.As a result, patient had an explantation on (b)(6) 2022.
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: deflation.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 june 20, 2022 the mentor failure analysis lab has received the device for evaluation.The investigation of the returned device was completed by the failure analysis lab on june 22, 2022.Device evaluation summary: 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 sal smooth rnd diap 125cc breast implant had a crease/fold on the anterior view.In addition, a tear was noted within the crease/fold measuring 0.3 cm.The evaluation determined that the cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in deflation at a later time.Breast implants may also wear out over time.It should be noted that as part of the mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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 ; 646591-7981
• MDR Report Key: 14705042
• Report Number: 1645337-2022-07047
• Device Sequence Number: 19377267
• Product Code: FWM
• UDI-Device Identifier: 00081317001171
• UDI-Public: 00081317001171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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

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: 06/17/2020
• Device Model Number: 3501610
• Device Catalogue Number: 3501610
• Device Lot Number: 7342910
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• 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: 73 YR
• Patient Sex: Female