MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	SCX-375
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 unknown.
Event or Problem Description
Healthcare professional reported rupture and capsular contracture baker grade unknown.Device has been explanted.This record is for the right side.
Event or Problem Description
Healthcare professional reported right-side rupture and capsular contracture, baker grade iv and hole non- specific.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5.
Event or Problem Description
Healthcare professional reported, right-side rupture.And capsular contracture, baker grade iv.And hole non- specific.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed, a broken assessed, as a surgical impact opening (shell thickness whiting to spec).Capsular contracture: unable to observe, as it is a medical event.Not related to the device.Additional observations: stress mark observed, on the device.No further actions are required, as the device was implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d4, d9, h3, h4, h6.
Event or Problem Description
Healthcare professional reported right-side rupture and capsular contracture, baker grade iv and hole non- specific.Device has been explanted.

• Brand Name: STYLE 15 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: 15999643
• Report Number: 9617229-2022-22431
• Device Sequence Number: 17520502
• Product Code: FTR
• UDI-Device Identifier: 10888628030282
• UDI-Public: 10888628030282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2023

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: 06/16/2013
• Device Model Number: SCX-375
• Device Catalogue Number: 15-397
• Device Lot Number: 1629240
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 01/04/2023; 01/19/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/28/2022; 01/20/2023; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 59 KG