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-410550
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's 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 iii, visibility/ palpability, anxiety-product/ procedure.
Event or Problem Description
Patient reported a left side "breast hardening" and a exchange from textured to smooth breast implants due to the patient¿s concern with the product.Healthcare professional reported a left side capsular contracture baker grade iii.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Event or Problem Description
Patient reported a left side "breast hardening" and a exchange from textured to smooth breast implants due to the patient¿s concern with the product.Healthcare professional reported a left side capsular contracture baker grade iii.Device has been explanted.
Event or Problem Description
Patient reported a left side "breast hardening" and a left side exchange from textured to smooth breast implants due to the patient¿s concern with the product.Healthcare professional reported a left side capsular contracture baker grade iii.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: weight to the spec.Cloudy and voids were observed after autoclave disinfection process.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 10167924
• Report Number: 9617229-2020-09183
• Device Sequence Number: 17053204
• Product Code: FTR
• UDI-Device Identifier: 10888628003774
• UDI-Public: 10888628003774
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2022

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: 03/21/2022
• Device Model Number: MX-410550
• Device Catalogue Number: MX-410550
• Device Lot Number: 3045222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 01/12/2022; 02/23/2022; 04/26/2022
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 02/08/2022; 03/23/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 91 KG