MAUDE Adverse Event Report: SIENTRA, INC. SIENTRA OPUS SILICONE GEL BREAST IMPLANT

Model Number	20610-XXXLP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ide study device, complete udi, expiration and manufacturing dates unavailable.
Event or Problem Description
Clinical study participant diagnosed with possible bilateral rupture via mri.Left side device.

• Brand Name: SIENTRA OPUS SILICONE GEL BREAST IMPLANT
• Common Device Name: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC.; 420 s fairview ave.; suite 200; santa barbara, ca
• MDR Report Key: 9892046
• Report Number: 1651189-2020-00226
• Device Sequence Number: 14144530
• Product Code: FTR
• UDI-Device Identifier: 00812790021147
• UDI-Public: 00812790021147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20610-XXXLP
• Device Catalogue Number: 20610-220LP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/27/2020
• 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: 56 YR