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

Model Number	3501410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.(b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a breast augmentation revision with a mentor smooth round spectrum 125cc saline breast prosthesis and experienced a deflation on the left side post-operatively, which was confirmed by a physician.As a result, the patient underwent explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On november 24, 2020, mentor completed evaluation of the device.Device evaluation summary: during the visual evaluation, an anomaly was observed on the anterior view of the device consistent with a crease/fold.A tear was also observed within the crease/fold, measuring approximately 0.3 cm.The evaluation determined that the loss of shell integrity is consistent with a crease fold deflation of the implant shell, which is a known inherent risk of saline-filled mammary prosthesis.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 a deflation in a later time.Breast implants may also simply wear out over time.A second product was received (product code 3501410 and lot number 5949064).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Deflation complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10742001
• Report Number: 1645337-2020-13712
• Device Sequence Number: 16925322
• Product Code: FWM
• UDI-Device Identifier: 00081317001959
• UDI-Public: 00081317001959
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 10/31/2013
• Device Model Number: 3501410
• Device Catalogue Number: 3501410
• Device Lot Number: 5949064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR