MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	20-475
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/15/2022
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: rupture and capsular contracture baker grade iv.
Event or Problem Description
Healthcare professional report right-side "encapsulation", "potentially/possible rupture", and " might appear hairageous with stepladder sign and inter-capsular rupture" and capsular contracture baker grade iv.The device remains implanted.
Event or Problem Description
Device has been explanted and replaced.
Event or Problem Description
Healthcare professional report right-side "encapsulation", "potentially/possible rupture", and " might appear hairageous with stepladder sign and inter-capsular rupture" and capsular contracture baker grade iv.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ capsular contracture: unable to observe as it is a medical event not related to the device.¿ rupture: no observed openings during analysis.¿ lump/nodule: unable to observe as it is a medical event not related to the device.Additional observations: ¿ observed deformation on the device.¿ white particles observed in the surface of the shell.¿ observed creases on the device.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare provider office called to report right-side "encapsulation", "potentially/possible rupture", and " might appear hairageous with stepladder sign and inter-capsular rupture" confirmed via mammogram/ultrasound.Right side capsular contracture baker grade iv.The ultrasound also reported "unspecified lump in breast".The device has been explanted.

• Brand Name: STYLE 20 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: 16762469
• Report Number: 9617229-2023-06232
• Device Sequence Number: 12260147
• Product Code: FTR
• UDI-Device Identifier: 10888628001732
• UDI-Public: 10888628001732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/01/2023

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: 01/21/2022
• Device Model Number: 20-475
• Device Catalogue Number: 20-475
• Device Lot Number: 3026170
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 06/22/2023; 07/17/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/16/2023; 07/14/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2017
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 76 KG