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

Model Number	110-360
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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.
Event or Problem Description
Patient reported left side rupture.Device remains implanted.
Additional Manufacturer Narrative
The event of capsular contracture, baker grade iii/iv is a physiological complication.And analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Physician reported, capsular contracture, baker grade iii/iv.And concerns with the product.Device has been explanted and replaced.
Event or Problem Description
Patient reported left side rupture.Physician reported capsular contracture, baker grade iii/iv and concerns with the product.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: "based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe as it is a medical event not related to the device.Rupture: no observed rupture on the device.Anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Additional observations: crease fold observed on the device.Deformation device observed on the device.Yellow particles observed on the device.No further actions are required as the device was implanted." additional, changed, and/or corrected data.

• 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: 14880879
• Report Number: 9617229-2022-10857
• Device Sequence Number: 14999345
• Product Code: FTR
• UDI-Device Identifier: 10888628002241
• UDI-Public: 10888628002241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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: 09/07/2019
• Device Model Number: 110-360
• Device Catalogue Number: 110-360
• Device Lot Number: 2661978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 10/20/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/30/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2014
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG