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

Catalog Number	3542460M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/18/2019
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 (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 (b)(6)-year-old hispanic female patient underwent a breast augmentation revision with a mentor siltex round spectrum 375cc and experienced deflation on the right breast implant.As a result, the patient will undergo removal on (b)(6) 2019.
Additional Manufacturer Narrative
On 9/5/2019, it was reported to mentor that the replacement devices were mentor smooth round spectrum 375cc.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: during evaluation of the sample, a line of shell wear was observed on the posterior aspect.Leak testing was performed in accordance with mentor procedures, and a tear was detected within the line of shell wear, measuring less that 0.1 cm.No additional anomalies were observed.The shell wear is consistent with continuous and sustained stresses to the device, such as too small a breast pocket and folding or wrinkling of the shell in the breast pocket.   the manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, it was reported to mentor that the concomitant product was a mentor siltex round spectrum 375cc, catalog number 3542460m, serial number 6773323-019, lot number 6773323.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 9/10/2019, 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.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: 8866547
• Report Number: 1645337-2019-16543
• Device Sequence Number: 16661613
• Product Code: FWM
• UDI-Device Identifier: 00081317002109
• UDI-Public: 00081317002109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/19/2019

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: 05/27/2020
• Device Catalogue Number: 3542460M
• Device Lot Number: 7335849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 09/11/2019; 09/11/2019; 09/17/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/05/2019; 09/11/2019; 09/11/2019; 09/17/2019
• 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: 48 YR