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	10/22/2018
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast reconstruction primary with a saline mentor siltex round spectrum 375 cc and experienced deflation on the right breast implant.The deflation was confirmed by the healthcare professional.As a result, the patient had undergone explantation on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the device history record (dhr) for the lot number 176221 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).
Additional Manufacturer Narrative
On 11/27/2018, it was reported to mentor that 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.(b)(4).
Additional Manufacturer Narrative
On 12/13/2018, it was reported to mentor that the device evaluation and investigation have been completed.The device contained no fluid, upon receipt by mentor.White material was observed within the device.No foreign material was observed on the shell surface.During visual examination, mentor product analysis lab observed the device appears intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.No 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.The complaint of deflation was not confirmed since no anomalies were found on the reported device.At this point it is not possible to determine the origin of the white material observed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.No corrective action is required since there is no evidence that the failures modes are related with manufacturing or product design.(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: 8100024
• Report Number: 1645337-2018-06989
• Device Sequence Number: 1833800
• Product Code: FWM
• UDI-Device Identifier: 00081317002109
• UDI-Public: 00081317002109
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2018

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: 07/31/2003
• Device Catalogue Number: 3542460M
• Device Lot Number: 176221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 12/06/2018; 12/13/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 11/27/2018; 12/06/2018; 12/14/2018
• 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: 50 YR