MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	110-150
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side rupture.Health professional reported complications such as rethoracic abnormal movement and capsular contracture (baker grade unknown) deformation.The device has been explanted and replaced.
Additional Manufacturer Narrative
H.6.Health effect - impact code: f2203.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: rupture and capsular contracture, baker grade unknown.
Additional Manufacturer Narrative
Photo analysis: visual analysis of the photographs identified, device patch with lot number#: 2707871 and catalog number: 110-150g.Rupture: observed, opening on the device.But, cannot perform an assessment of the opening, as no microscopic analysis can be performed.Capsular contracture: unable to observe, since it is not related to the device.Migration: unable to observe, since it is not related to the device.No additional observations are performed.
Event or Problem Description
Healthcare professional reported, "that ¿rupture for right side.Replace for only right side".¿capsular contracture¿ and ¿deformation¿ and "rethoracic abnormal movement¿.The device has been explanted.
Event or Problem Description
Patient reported right side rupture.Health professional reported complications such as rethoracic abnormal movement and capsular contracture (baker grade unknown) deformation.The device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture : observed, broken side assessed as fold flaw opening and missing side assessed as inconclusive.Migration: unable to observe since it is a medical event and is not related to the device.Capsular contracture : unable to observe since it is a medical event and is not related to the device.Additional observation: no penetrating nick.

• Brand Name: STYLE 110 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17965380
• Report Number: 9617229-2023-16719
• Device Sequence Number: 15153496
• Product Code: FTR
• UDI-Device Identifier: 10888628002173
• UDI-Public: 10888628002173
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2024

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: 01/18/2020
• Device Catalogue Number: 110-150
• Device Lot Number: 2707871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 02/13/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/27/2023; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2015
• 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: 61 YR
• Patient Sex: Female