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 Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances 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
Patient reported rupture.Device remains implanted.This relates to the right side.
Additional Manufacturer Narrative
Device 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, crease is observed.It is not possible to determine, the lot number or catalog through the photos provided.
Event or Problem Description
The device has been explanted and replaced.
Event or Problem Description
The device has been explanted and replaced with non allergan device.
Additional Manufacturer Narrative
Device evaluation: the device is a silicone device.Based on the device analysis grid, the assessments of the complaint are: rupture: observed, an opening on anterior assessed, as fold flaw opening.Additional observations: crease fold and wear abrasion observed, on the device.Brown particles observed, on the device.No further actions are required, as the device was implanted.
Event or Problem Description
Patient reported, right side rupture.Device has been explanted and replaced with a 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: 16380138
• Report Number: 9617229-2023-01949
• Device Sequence Number: 5759611
• 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): 11/16/2023

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: 09/30/2020
• Device Model Number: FX-410690
• Device Catalogue Number: FX-410690
• Device Lot Number: 2823334
• 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; 03/28/2023; 10/25/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/28/2023; 04/14/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2015
• 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