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

Catalog Number	3542440M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/19/2019
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 for the finished device number 84477, and no non-conformances related to the reported complaint condition were identified.Concomitant products: mentor siltex round spectrum 275cc prosthesis, catalog #3542440m, lot #96815.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female underwent breast reconstruction revision with a mentor siltex round spectrum 275cc prosthesis and experienced right sided deflation post procedure.The deflation was diagnosed by a physician.As a result, an explant is planned for (b)(6) 2019.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 6/12/2019.Device evaluation summary: according to the information provided, it was reported that the patient experienced a deflation of the implant.During evaluation of the sample, it appeared intact.Leak testing was performed, and it revealed a tear measuring approximately 0.4 cm in the posterior view.Microscopic examination was performed and no evidence of instrument damage was observed.No other anomalies were observed.Possible causes of deflation of saline-filled implants include, but are not limited to, the following events: excessive stresses or manipulations as may occur during normal daily routines including customary and purposeful trauma to the breast.The reported complaint was confirmed.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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.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: 8430726
• Report Number: 1645337-2019-09431
• Device Sequence Number: 13502323
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1995
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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 Catalogue Number: 3542440M
• Device Lot Number: 84477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/24/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR