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

Model Number 10621-XXXMP

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

Gel fracture, left side.

Manufacturer Narrative

Sientra complaint #: case (b)(4).Sientra received the suspected device from the customer and performed a failure analysis.The device was returned intact and functional.No additional observations.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANT
• Type of Device: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC.; 3333 michelson dr. suite 650; irvine CA 92612
• Manufacturer (Section G): SIENTRA INC.; 3333 michelson dr. suite 650; irvine CA 92612
• Manufacturer Contact: denise dajles ; 8055623500
• MDR Report Key: 16490542
• MDR Text Key: 310740639
• Report Number: 1651189-2023-04181
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10621-XXXMP
• Device Catalogue Number: 10621-455MP
• Device Lot Number: 101059702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/03/2023
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female