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

Catalog Number	3542450M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2018
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.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 products: saline mentor siltex round spectrum 325cc, catalog number 3542450m, serial number (b)(4), lot number 5942461.(b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old caucasian female patient underwent a breast augmentation primary with a saline mentor siltex round spectrum 325cc and experienced deflation on the right side post-operatively.Deflation was confirmed by physician during exam.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
Additional information received on 11/21/2018 indicated the patient underwent bilateral removal and replacement with mentor memorygel breast implant 425cc, catalog number 3544251, serial number (b)(4), lot number 6789548 (l) and serial number (b)(4), lot number 6869641 (r) on (b)(6) 2018.(b)(4).
Additional Manufacturer Narrative
The following information was mistakenly omitted from the medwatch report submitted on 12/13/2018.On (b)(6) 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.Date received by manufacturer was mistakenly entered as (b)(6) 2018 in the medwatch report submitted on 12/13/2018.The correct date should be 11/20/2018.(b)(4).
Additional Manufacturer Narrative
On 1/2/2019, it was noticed that the report submission due date for mwr (b)(4) was erroneously entered as 1/12/2018.The correct due date is 1/12/2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device returned with clear fluid.No foreign material was observed within the device or on the shell surface.Mentor product analysis lab discovered the tube broken with evidence of leakage.Microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.There is no evidence that the issue is related with manufacturing.The complaint was confirmed.Microscopic examination of the edges of the rent revealed parallel striations which are similar to markings made by an instrument perforating silicone material.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).

• 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: 7924309
• Report Number: 1645337-2018-05905
• Device Sequence Number: 1786613
• Product Code: FWM
• UDI-Device Identifier: 00081317002093
• UDI-Public: 00081317002093
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/10/2018

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: 09/30/2013
• Device Catalogue Number: 3542450M
• Device Lot Number: 5942461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 12/13/2018; 01/02/2019; 03/07/2019
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/13/2018; 12/13/2018; 01/02/2019; 03/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 42 YR