MAUDE Adverse Event Report: Allergan (Costa Rica) Style 10 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	10-180
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Event or Problem Description
Later, healthcare professional reported "capsular contracture baker grade iii.".
Additional Manufacturer Narrative
Additional, changed, and/or corrected: a5, a6, b5, b6, d1, d2a, d2b, d6a, g4, h2, h4 and h6.Reason for reoperation: capsular contracture baker grade iii.Continued e1: alternate email addresses: (b)(6).Continued e1: alternate phone number:(b)(6).

• Brand Name: Style 10 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; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50624725
• Report Number: 9617229-2026-16944
• Device Sequence Number: 10663753
• Product Code: FTR
• UDI-Device Identifier: 10888628001206
• UDI-Public: (01)10888628001206(17)170310
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 03/10/2017
• Device Catalogue Number: 10-180
• Device Lot Number: 2269025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/05/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 04/10/2012
• 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 Sex: Female
• Patient Race: White