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

Catalog Number	FX-410690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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 a right side exchange due to concerns with the product, healthcare professional later reported right "rupture".Device was explanted.
Additional Manufacturer Narrative
Only device photos were received.Visual analysis: visual analysis of the photographs identified: ¿ rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.¿ anxiety-product/procedure: unable to observe as it is not related to the device.¿ migration: unable to observe as it is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional reported a right side exchange due to concerns with the product.Healthcare professional later reported "rupture." healthcare professional additionally reported migration.Device has been explanted and replaced with non-allergan device.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture : observed, broken assessed as fold flaw opening.¿ anxiety-product/procedure: unable to observe since it is a medical event and is not related to the device.¿ migration : unable to observe since it is a medical event and is not related to the device.Additional observation.¿ no penetrating nick ( stress marks).No further actions are required as no issues with the manufacturing process are observed.
Event or Problem Description
Healthcare professional reported a right side exchange due to concerns with the product.Healthcare professional later reported "rupture." healthcare professional additionally reported migration.Device has been explanted and replaced with non-allergan device.

• 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: 18370002
• Report Number: 9617229-2023-19975
• Device Sequence Number: 18092095
• Product Code: FTR
• UDI-Device Identifier: 10888628003033
• UDI-Public: 10888628003033
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/01/2024

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: 03/20/2022
• Device Catalogue Number: FX-410690
• Device Lot Number: 3045354
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/11/2024; 02/23/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/17/2024; 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2017
• 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 Sex: Female
• Patient Weight: 69 KG