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-410690
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Swollen Lymph Nodes/Glands (4432)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported rupture.Device remains implanted.This relates to the left side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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.
Additional Manufacturer Narrative
Photo analysis: visual analysis of the photographs identified: ¿ rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.Additional observations: ¿ red particles on the surface of the shell.It is not possible to determine the lot number or catalog through the photos provided.
Event or Problem Description
Device has been explanted and replaced with a non-allergan device.
Event or Problem Description
Patient reported left side rupture.Additional events of "axillary left siliconomas" and "in internal mammary chains" through mri.Device has been explanted and replaced with non-allergan device.
Event or Problem Description
Patient reported left side rupture.Additional events of "axillary left siliconomas" and "in internal mammary chains" through mri.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 crease sharp opening on anterior assessed as fold flaw opening.Additional observations: crease fold observed.Wear abrasion observed.No further actions are required as no manufacturing issues are observed.

• 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: 16380091
• Report Number: 9617229-2023-02412
• Device Sequence Number: 6279189
• Product Code: FTR
• UDI-Device Identifier: 10888628003033
• UDI-Public: 10888628003033
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/17/2023

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: 09/21/2020
• Device Model Number: FX-410690
• Device Catalogue Number: FX-410690
• Device Lot Number: 2820735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 04/05/2023; 10/26/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/29/2023; 04/21/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2015
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 74 KG