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-410280
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/27/2020
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 baker grade baker grade iii" 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 and patient's concern with the product.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii and exchange from textured to smooth due to concern with the product.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: one opening curved on the radius, brown biological tissue on the shell, brown particles on the shell, and overweight.A microscopic analysis was performed which identified: one opening sharp and non-penetrating nick, near of the opening site, this condition was called surgical impact.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis the final assessment is: one sharp opening on the radius assessed as surgical impact.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii and exchange from textured to smooth due to concern with the product.Device has been explanted.

• 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: 10979272
• Report Number: 9617229-2020-20297
• Device Sequence Number: 13628926
• Product Code: FTR
• UDI-Device Identifier: 10888628002951
• UDI-Public: 10888628002951
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 11/17/2019
• Device Model Number: FX-410280
• Device Catalogue Number: FX-410280
• Device Lot Number: 2685105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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 Age: 78 YR
• Patient Weight: 64