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

Model Number	3542914
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: not applicable.Concomitant medical products: 425cc mentor silex contour profile moderate saline breast implant (catalog number 3542914; lot number 189291) manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation with a 425cc mentor silex contour profile moderate saline breast implant and experienced postoperative left-sided deflation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2021, 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 was discarded and not available for analysis.Device evaluation summary: according to the information received, the patient experienced deflation in the left breast implant.Additionally, it was reported that the implant was discarded.Upon visual evaluation of the image provided in the complaint, the device was observed to be deflated.In addition, a yellowish coloration on the shell was noted.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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor received additional information regarding the revision surgery and condition of the suspected medical device.The patient underwent explantation on (b)(6) 2021.Updated reason for device explant and/or reoperation: deflation.The device was discarded inadvertently and is not available for product evaluation.The relevant fields have been updated.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR SILEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8957015
• Report Number: 1645337-2019-18309
• Device Sequence Number: 2559737
• Product Code: FWM
• UDI-Device Identifier: 00081317001881
• UDI-Public: 00081317001881
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2019

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: 02/28/2003
• Device Model Number: 3542914
• Device Catalogue Number: 3542914
• Device Lot Number: 189291
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 01/15/2021; 03/18/2021
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 02/06/2021; 03/19/2021
• 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: Other; Required Intervention
• Patient Age: 47 YR