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

Model Number	10621-XXXHP
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Left-side capsular contracture, baker grade 3.
Additional Manufacturer Narrative
The device was returned intact and functional.No additional observation.

• Brand Name: SIENTRA OPUS SILICONE GEL BREAST IMPLANT
• Common Device Name: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC.; 420 s fairview suite 200; santa barbara CA 93117
• Manufacturer (Section G): SIENTRA INC.; 420 s fairview suite 200; santa barbara CA 93117
• Manufacturer Contact: denise dajles ; 8055623500
• MDR Report Key: 13518933
• Report Number: 1651189-2022-02099
• Device Sequence Number: 4207293
• Product Code: FTR
• UDI-Device Identifier: 00812790024438
• UDI-Public: 00812790024438
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 07/22/2026
• Device Model Number: 10621-XXXHP
• Device Catalogue Number: 10621-470HP
• Device Lot Number: 100995111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female