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-410615
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "a right side capsular contracture baker grade iv with "pain", "fold reported with ultrasound on (b)(6) 2022" and "firmness." device remains implanted.
Additional Manufacturer Narrative
(b)(6).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 iv and crease folding of implant.
Event or Problem Description
Device explanted.
Event or Problem Description
Healthcare professional additionally reported right side "grossly ruptured".
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 that is not related to the device.Crease/folding of implant: crease flat is observed on the device.Rupture: observed, broken on radius side assessed as unidentified (tear) opening (shell thickness within specification).Additional observations: red particles on the shell and gel are observed.Crease flat is observed.Wear abrasion is observed.No further actions are required as the device was implanted.

• 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: 15663117
• Report Number: 9617229-2022-18581
• Device Sequence Number: 6470423
• Product Code: FTR
• UDI-Device Identifier: 10888628003026
• UDI-Public: 10888628003026
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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: 12/05/2021
• Device Model Number: FX-410615
• Device Catalogue Number: FX-410615
• Device Lot Number: 3003366
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 11/21/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/21/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2017
• 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: 62 YR
• Patient Sex: Female