MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	120-600
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30-calendar days from allergan¿s receipt due to the exemption transition period.A review of the device history record has been completed.No deviations or non-conformances 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.Device evaluation: analysis of the returned device identified: weight to the spec, deformation device, creases fold and white particles.Cloudy in the gel observed after autoclave cycle.The unit is not rupture.Base on the device analysis the final assessment is: no issues found related with the manufacturing process.Reason for reoperation was due to capsular contracture baker grade iv and a rupture.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side capsular contracture baker grade iv and a rupture.Device has been explanted.
Event or Problem Description
Healthcare professional reported a left side capsular contracture baker grade iv and a rupture.Device has been explanted.

• Brand Name: STYLE 120 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: 8856929
• Report Number: 9617229-2019-04260
• Device Sequence Number: 19423454
• Product Code: FTR
• UDI-Device Identifier: 10888628002593
• UDI-Public: 10888628002593
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: 12/06/2020
• Device Catalogue Number: 120-600
• Device Lot Number: 2846182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 34 YR