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

Model Number	10621-XXXMP
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Left-side capsular contracture baker grade 4.
Additional Manufacturer Narrative
Sientra complaint#: (b)(4).Sientra was unable to perform an evaluation as the device was discarded by the customer.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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: 13742568
• Report Number: 1651189-2022-02259
• Device Sequence Number: 14604251
• Product Code: FTR
• UDI-Device Identifier: 00819409023868
• UDI-Public: 00819409023868
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 08/18/2022

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: 05/03/2026
• Device Model Number: 10621-XXXMP
• Device Catalogue Number: 10621-285MP
• Device Lot Number: 100942845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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: 64 YR
• Patient Sex: Female