MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	120-500
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes/Glands (4432)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side rupture and "textured implants".Device remains implanted.
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
Healthcare professional reported additional event of "right axilla level 1 lymph nodes consistent with silicone lymphadenopathy" through mri results.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: visibility/palpability: unable to observe as it is a medical event not related to the device.Capsular contracture: unable to observe as it is a medical event not related to the device.Rupture: one opening observed on posterior side assessed as surgical impact opening (shell thickness was within specification), broken observed on anterior side assessed as surgical damage and missing shell assessed as inconclusive.Anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Additional observations: creases were observed.Wear abrasion observed.Stress marks observed.Yellow particles observed on the surface of the shell.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional reported right side rupture and "textured implants".Healthcare professional reported additional event of "right axilla level 1 lymph nodes consistent with silicone lymphadenopathy" through mri results.Device has been explanted and replaced.

• Brand Name: STYLE 120 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: 16558849
• Report Number: 9617229-2023-03801
• Device Sequence Number: 5535474
• Product Code: FTR
• UDI-Device Identifier: 10888628002579
• UDI-Public: 10888628002579
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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: 10/07/2019
• Device Model Number: 120-500
• Device Catalogue Number: 120-500
• Device Lot Number: 2671052
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 07/12/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/02/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2014
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 61 KG