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

Model Number	120-500
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformities noted.Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety-product/procedure : unable to observe since it is a medical event and is not related to the device.Visibility/palpability : unable to observe since it is a medical event and is not related to the device.Pain : unable to observe since it is a medical event and is not related to the device.Additional observations: deformation observed on the device.Voids observed on the gel.Crease fold observed on the device.Observed 40 mm dark patch edge material inside gel device.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 grade iv.
Event or Problem Description
Patient reported right side exchange from textured to smooth implants due to the patient's concerns with the product with "incredible pain, hardness" and "my breast was black at 2 weeks post op.'' healthcare professional later reported "capsular contracture," baker grade iv.Device has been explanted and replaced.
Event or Problem Description
Patient reported right side exchange from textured to smooth implants due to the patient's concerns with the product with "incredible pain, hardness" and "my breast was black at 2 weeks post op.'' healthcare professional later reported "capsular contracture," baker grade iv.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: assessment for complaint that was previously not included in evaluation.Capsular contracture: unable to observe since it is a medical event and is not related to the device.

• 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
• 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: 17256487
• Report Number: 9617229-2023-11726
• Device Sequence Number: 20348183
• Product Code: FTR
• UDI-Device Identifier: 10888628002579
• UDI-Public: 10888628002579
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 12/04/2020
• Device Model Number: 120-500
• Device Catalogue Number: 120-500
• Device Lot Number: 2845649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2016
• 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 Weight: 71 KG