MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	FX-410495
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect - impact code: f2203 - imaging required.A review of the device history record has been completed.No deviations or non-conformities noted.The event of lymphadenopathy is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: lymphadenopathy.
Event or Problem Description
Healthcare professional reported "increasing hypermetabolic activity of a few right internal mammary nodules".The device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported via sus voluntary event report "suspected rupture" and "device malfunction-that is, the device did not do what it was supposed to do.".
Additional Manufacturer Narrative
Reason for reoperation: rupture.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are ¿ anxiety-product/procedure: unable to observe since it is a medical event and is not related to the device.¿ rupture: not observed.¿ lymphadenopathy: unable to observe since it is a medical event and is not related to the device.Additional observations: ¿ crease is observed.¿ deformation is observed.¿ wear abrasion is observed.
Event or Problem Description
Healthcare professional reported "increasing hypermetabolic activity of a few right internal mammary nodules".Healthcare professional reported via sus voluntary event report "suspected rupture" and "device malfunction-that is, the device did not do what it was supposed to do." the device has been explanted and replaced.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16632362
• Report Number: 9617229-2023-04562
• Device Sequence Number: 19971186
• Product Code: FTR
• UDI-Device Identifier: 10888628003002
• UDI-Public: 10888628003002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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: 08/03/2021
• Device Model Number: FX-410495
• Device Catalogue Number: FX-410495
• Device Lot Number: 2955318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 06/23/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/14/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2016
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic