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-410410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes/Glands (4432)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformities noted.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: rupture.
Event or Problem Description
Healthcare professional reported rupture.The device remains implanted.This relates to the right side.
Additional Manufacturer Narrative
Device evaluation: october 03, 2023, with lot number#: 2685108.Based on the device analysis grid, the assessments of the complaint are: anxiety-product/procedure: unable to observe, as it is a medical event not related to the device.Rupture: no observed, openings on the device.Lymphadenopathy: unable to observe, as it is a medical event.Not related to the device.Double capsule: unable to observe, as it is a medical event.Not related to the device.Additional observations: deformation observed, creases observed, black mold like appearance observed, yellow encapsulation observed, wear abrasion observed.
Event or Problem Description
Healthcare professional reported, a right side rupture."double capsule".And implant exchange, due to patient's concern with the product.Patient's spouse, later also reported, rupture and "silicone in lymph nodes".Device has been explanted.
Additional Manufacturer Narrative
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.
Event or Problem Description
Healthcare professional reported a right side rupture, "double capsule", and implant exchange due to patient's concern with the product.Patient's spouse later also reported rupture and "silicone in lymph nodes".Device has been explanted.

• 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: 17256278
• Report Number: 9617229-2023-10851
• Device Sequence Number: 12754216
• Product Code: FTR
• UDI-Device Identifier: 10888628002982
• UDI-Public: 10888628002982
• 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: 2015
• 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): 11/09/2023

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: 11/29/2019
• Device Model Number: FX-410410
• Device Catalogue Number: FX-410410
• Device Lot Number: 2685108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 10/19/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/29/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2014
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG