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

Model Number	20621-XXXMP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Left implant rupture, discovered during surgery.
Additional Manufacturer Narrative
Customer confirmed that the device was discarded.No device analysis was performed.

• 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: 13085656
• Report Number: 1651189-2021-01866
• Device Sequence Number: 12103637
• Product Code: FTR
• UDI-Device Identifier: 00812790021536
• UDI-Public: 00812790021536
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted 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): 04/13/2022

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 Model Number: 20621-XXXMP
• Device Catalogue Number: 20621-355MP
• Device Lot Number: 2679048
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/26/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 42 YR
• Patient Sex: Female