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

Catalog Number	120-440
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/16/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side "textured implants".Device has been explanted.Healthcare professional later reported "left side device found ruptured during explant" and "capsular contracture baker grade iii".
Additional Manufacturer Narrative
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.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: replacement of textured device.Rupture found upon explant.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2, b3, h3, h6.Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture: broken device observed assessed as unidentified (tear) opening.(shell thickness was within specification).Missing shell assessed as inconclusive.¿ anxiety ¿ product/procedure: unable to observe as it is not related to the device.¿ capsular contracture: unable to observe as it is not related to the device.No other observations observed.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported left side "textured implants".Device has been explanted.Healthcare professional later reported "left side device found ruptured during explant" and "capsular contracture baker grade iii".

• 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; 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18785188
• Report Number: 9617229-2024-03196
• Device Sequence Number: 12836429
• Product Code: FTR
• UDI-Device Identifier: 10888628002562
• UDI-Public: 10888628002562
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 05/08/2017
• Device Catalogue Number: 120-440
• Device Lot Number: 2298624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2012
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White