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

Model Number	MX-410325
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
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 and patient's concern with the product.
Event or Problem Description
Healthcare professional reported right side rupture and exchange from textured to smooth implants due to the patient's concern with the product.Device has been explanted.
Additional Manufacturer Narrative
Device photo evaluation: visual analysis of the photographs: one device appears to be intact, along with red biological tissue labeled right side.
Event or Problem Description
Capsular contracture identified as baker grade iii.
Additional Manufacturer Narrative
The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Event or Problem Description
Healthcare professional later reported capsular contracture, baker grade unknown and silicone migration.

• 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; CS
• MDR Report Key: 10665304
• Report Number: 9617229-2020-16406
• Device Sequence Number: 11773239
• Product Code: FTR
• UDI-Device Identifier: 10888628003729
• UDI-Public: 10888628003729
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2020

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: 12/07/2019
• Device Model Number: MX-410325
• Device Catalogue Number: MX-410325
• Device Lot Number: 2690467
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/18/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/17/2020; 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 61