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-410775
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/11/2021
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.The event of seroma-late 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: rupture, seroma-late, silicone migration, anxiety-product/procedure, pain-ndr, varied injuries-ndr.
Event or Problem Description
Patient reported right side "rupture", "elevated liver enzymes", "joint pain", "brain fog", "hair loss", "fluid around implant", "silicone poisoning", and exchange from textured to smooth due to concern with the product.The events of pain, elevated liver enzymes, brain fog, and hair loss are not device related.Device remains implanted.
Event or Problem Description
The device has been explanted.
Event or Problem Description
Patient reported right side "rupture", "elevated liver enzymes", "joint pain", "brain fog", "hair loss", "fluid around implant", "silicone poisoning", and exchange from textured to smooth due to concern with the product.The events of pain, elevated liver enzymes, brain fog, and hair loss are not device related.Device remains implanted.
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 not related to the device.Pain ¿ ndr: unable to observe since it is not related to the device.Varied injuries ¿ ndr: unable to observe since it is not related to the device.Silicone migration: unable to observe since it is not related to the device.Rupture : observed broken device assessed as fold flaw opening.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
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: 17031250
• Report Number: 9617229-2023-09519
• Device Sequence Number: 6459708
• Product Code: FTR
• UDI-Device Identifier: 10888628003040
• UDI-Public: 10888628003040
• Combination Product (Y/N): N
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2023

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: 09/26/2021
• Device Model Number: FX-410775
• Device Catalogue Number: FX-410775
• Device Lot Number: 2979283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 10/23/2023; 11/13/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 10/20/2023; 10/23/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 103 KG