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

Model Number	3542460M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/18/2019
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Concomitant medical products: 375cc mentor siltex round spectrum saline breast implant (catalog number 3542460m, lot number 207798).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast agumentation with 375cc mentor siltex round spectrum saline breast implants and experienced postoperative right-sided deflation.The diagnosis was confirmed by a physician upon examination.As a result, the patient's impacted device will be explanted on (b)(6) 2019.
Additional Manufacturer Narrative
Mentor received an update on the events submitted in the initial report.The patient's explantation is currently scheduled for (b)(6) 2020.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 1/23/2020, 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).
Additional Manufacturer Narrative
Mentor became aware of event information that was mistakenly omitted from the previous supplemental report.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.The manufacture date and expiration date have been updated as well.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.Device investigation summary: during evaluation of the device, an area of siltex cracking was observed on the posterior view.A tear was also noted within the siltex cracking measuring approximately 0.5 cm.The evaluation determined that the rupture is consistent with a siltex cracking.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Mentor believes that siltex cracking is ultimately a result of high stresses caused by acute folds in shell of siltex breast implants.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.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: 9392849
• Report Number: 1645337-2019-24594
• Device Sequence Number: 2659357
• Product Code: FWM
• UDI-Device Identifier: 00081317002109
• UDI-Public: 00081317002109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/08/2019

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: No Information
• Device Expiration Date: 02/29/2004
• Device Model Number: 3542460M
• Device Catalogue Number: 3542460M
• Device Lot Number: 207798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 01/23/2020; 02/19/2020; 02/19/2020
• Initial Report FDA Received Date: 12/01/2019
• Supplement Report FDA Received Date: 12/31/2019; 01/27/2020; 02/19/2020; 02/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR