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 Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	09/25/2018
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.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) white hispanic female patient underwent a primary breast augmentation with a mentor siltex round spectrum 325cc saline breast prosthesis (left device) and a mentor memorygel breast implant 350cc gel breast prosthesis (right device).The valve in the left breast prosthesis was protruding out and pushing through the skin.The doctor¿s office diagnosed it as a defective projector valve.In addition, the patient developed capsular contracture (baker grade iii) in both breasts.As a result, the patient underwent bilateral explantation on (b)(6) 2018.This medwatch report is for the left breast prosthesis.
Additional Manufacturer Narrative
On 11/05/2018, mentor received additional information about the event.It was initially reported that the patient had her breast prostheses removed on (b)(6) 2018.New information states that explantation has not occurred and that the suspected medical device is still implanted in the patient.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: 8031309
• Report Number: 1645337-2018-06580
• Device Sequence Number: 289270
• Product Code: FWM
• UDI-Device Identifier: 00081317002093
• UDI-Public: 00081317002093
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 08/31/2018
• Device Catalogue Number: 3542450M
• Device Lot Number: 6852790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR