MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	115-435
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
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.The event of capsular contracture 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: capsular contracture, baker grade iii/iv.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii/iv.Device remains implanted.
Event or Problem Description
Device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii/iv and rupture.Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6a.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed, broken device.And one opening on radius side assessed, as unidentified (tear) opening (shell thickness within specification).And one opening on anterior side assessed, as surgical damage.Missing shell assessed, as inconclusive.Capsular contracture: unable to observe, since it is a medical event.And is not related to the device.Additional observations: crease is observed, wear abrasion is observed.No further actions are required, as the device was implanted.
Event or Problem Description
Healthcare professional reported, left side capsular contracture, baker grade iii/iv.And rupture.Device has been explanted and replaced.

• Brand Name: STYLE 115 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: 16264223
• Report Number: 9617229-2023-00954
• Device Sequence Number: 11805625
• Product Code: FTR
• UDI-Device Identifier: 10888628002425
• UDI-Public: 10888628002425
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2023

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: 09/10/2019
• Device Model Number: 115-435
• Device Catalogue Number: 115-435
• Device Lot Number: 2661980
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 05/16/2023; 07/13/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/26/2023; 06/06/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2014
• 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 Sex: Female
• Patient Weight: 65 KG