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

Catalog Number	3542470M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant medical products: saline mentor siltex round spectrum 425cc breast implant , lot number 5862833.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
On (b)(6) 2018, saline mentor siltex round spectrum 425cc breast implants were received by the mentor failure analysis lab with no accompanying information.The devices could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, it will be conservatively reported to fda as an event requiring medical device removal from a patient.This medwatch is for the left breast implant.
Additional Manufacturer Narrative
On 05/22/18, it was reported to mentor that the device history record (dhr) for the lot number 5862833 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 06/15/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device was received without fluid.Brown material was observed within device.Device appears with shell wear on the anterior aspect.No other anomalies were observed.A root cause of the failure could not be determined.Corrective action: because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.Blind device received in product evaluation lab with no complaint information attached and could not be associated with an existing complaint.Device appears with shell wear on the anterior aspect.No other anomalies were observed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 06/22/18, it was reported to mentor that the device evaluation and investigation have been completed on (b)(6) 2018.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: 7520880
• Report Number: 1645337-2018-02976
• Device Sequence Number: 1224618
• Product Code: FWM
• UDI-Device Identifier: 00081317002116
• UDI-Public: 00081317002116
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/27/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 3542470M
• Device Lot Number: 5862833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018; 04/27/2018; 04/27/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/22/2018; 06/18/2018; 06/25/2018
• 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