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

Model Number	120-650
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/15/2020
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.The event of "capsular contracture unknown baker grade" 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 unknown baker grade.
Event or Problem Description
Patient reported left side pain with capsular contracture, baker grade unknown.The device remains implanted.
Event or Problem Description
Healthcare professional reported left side capsular contracture as baker grade iv.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, crease fold, wear abrasion, deformation yellow particles on the shell, and overweight (even though the device is currently overweight, it is not considered a workmanship since all units of the weight report attached are within specification when released in the manufacturing process).After autoclave cycle was observed: cloudy color in the gel.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Patient reported left side pain with capsular contracture, baker grade unknown.Healthcare professional reported left side capsular contracture as baker grade iv.Device has been explanted and replaced.

• 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: 12013384
• Report Number: 9617229-2021-07509
• Device Sequence Number: 4379720
• Product Code: FTR
• UDI-Device Identifier: 10888628002609
• UDI-Public: 10888628002609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

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: 11/03/2019
• Device Model Number: 120-650
• Device Catalogue Number: 120-650
• Device Lot Number: 2681271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/28/2022; 08/05/2022
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/25/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2014
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 57 KG