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

Model Number	FF-410425
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924)
Date of Event	03/21/2023
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
Healthcare professional reported a possible right side rupture.Device remains implanted.
Event or Problem Description
Healthcare professional later confirmed a right side rupture, "biocell implants, membranous scar like fibrosis consistent with implant capsule, foreign material present consistent with silicone, and minimal patchy chronic inflammation".Device has been explanted and replaced.
Additional Manufacturer Narrative
The event of granuloma is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for the event.
Event or Problem Description
Healthcare professional reported a possible right side rupture.Healthcare professional later confirmed a right side rupture, "biocell implants, membranous scar like fibrosis consistent with implant capsule, foreign material present consistent with silicone, and minimal patchy chronic inflammation".Device has been explanted and replaced.
Additional Manufacturer Narrative
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 a medical event that is not related to the device.Granuloma: unable to observe as it is a medical event that is not related to the device.No additional observations are performed.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: 17320100
• Report Number: 9617229-2023-11353
• Device Sequence Number: 6573431
• Product Code: FTR
• UDI-Device Identifier: 10888628002685
• UDI-Public: 10888628002685
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2023

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: 10/26/2019
• Device Model Number: FF-410425
• Device Catalogue Number: FF-410425
• Device Lot Number: 2678839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 11/07/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 11/01/2023; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2014
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 57 KG