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

Model Number	3542912
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.(b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision with mentor siltex contour profile moderate 275cc and suffered from a bilateral saline breast implant deflation.The left breast implant was completely deflated.As a result, the patient had undergone removal and replacement with mentor smooth round moderate plus profile 300cc on (b)(6) 2020.This medwatch is for the right breast implant.
Additional Manufacturer Narrative
On (b)(6) 2021 , the mentor failure analysis lab has received the device for evaluation.The right side lot number was 6771885-003, serial number was (b)(6).A manufacturing record evaluation (mre) was performed for the finished device number 6771885, and no non-conformances related to the reported complaint were identified.On (b)(6) 2021, during visual evaluation of the device no apparent damage was observed.Leak testing was performed, according to mentor procedure, and it revealed a tear within an area of siltex cracking on the posterior view, measuring approximately 0.6 cm.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.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 SILTEX 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: 10954105
• Report Number: 1645337-2020-15501
• Device Sequence Number: 3006710
• Product Code: FWM
• UDI-Device Identifier: 00081317001867
• UDI-Public: 00081317001867
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 10/31/2017
• Device Model Number: 3542912
• Device Catalogue Number: 3542912
• Device Lot Number: 6771885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: Required Intervention
• Patient Age: 45 YR