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

Catalog Number	3542480M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/07/2018
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.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant medical products: saline mentor siltex round spectrum 475cc, catalog number 3542480m, serial number (b)(4), lot number 6774344.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian male patient underwent a breast augmentation with a saline mentor siltex round spectrum 475cc breast implant and experienced deflation on the left side.Deflation was confirmed by physician during exam.As a result, the patient underwent removal on (b)(6) 2018.
Additional Manufacturer Narrative
Additional information received on 12/4/2018 indicated the patient underwent bilateral removal and replacement with saline mentor smooth round high profile 420cc, catalog number 3503420, serial number (b)(4), lot number 7623279 (l) and serial number (b)(4), lot number 7533201 (r).On 12/17/2018, the mentor failure analysis lab 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained no fluid.White, yellow, and brown material were observed within the device.White and yellow material were observed on the shell surface.During visual examination of the device, mentor product analysis lab observed a rent extending to both views and measuring approximately 0.5 cm.Microscopic examination of the rent edges gave no indication as to its cause.No other anomalies were found.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint of deflation was confirmed since a rent was found on the device.Nonetheless, a microscopic examination of the rent edges was performed, and it did not provide conclusive evidence of what could be the root cause.At this point it is not possible to determine the origin of the white, yellow, and brown material observed.There is no evidence that the issue is related with manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Patient sex was erroneously entered as m in the 1645337-2018-07175 initial report submitted on 12/3/2018.Patient sex is female.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The report due date was erroneously omitted in the follow-up report 1645337-2018-07175 submitted on (b)(6) 2019.The correct due date for the report is (b)(6) 2019.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX 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: 8125747
• Report Number: 1645337-2018-07175
• Device Sequence Number: 2166038
• Product Code: FWM
• UDI-Device Identifier: 00081317002123
• UDI-Public: 00081317002123
• Combination Product (Y/N): N
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/12/2018

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: 08/31/2018
• Device Catalogue Number: 3542480M
• Device Lot Number: 6852791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 01/10/2019; 02/27/2019; 03/07/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/27/2018; 01/11/2019; 02/27/2019; 03/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR