MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	20-475
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/24/2023
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 per mri.Device remains implanted.
Event or Problem Description
Later healthcare professional reported left side rupture and "the left breast implant appears somewhat lobulated".Later, patient reported "removal of both implants due to rupture.Due to rupture it is medically necessary due to silicone leaking into body.The implants are also part of the recall group." device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9, h.3, h.6, device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture : observed, opening on the posterior side assessed as surgical impact opening.(shell thickness was within specification).Anxiety-product/procedure : unable to observe since it is a medical event and is not related to the device.Wrinkling : observed on the device.Additional observation.No penetrating nick ( stress marks).No further actions are required as no issues with the manufacturing process are observed.
Event or Problem Description
Patient reported left side rupture.Later healthcare professional reported left side rupture and "the left breast implant appears somewhat lobulated".Later, patient reported "removal of both implants due to rupture.Due to rupture it is medically necessary due to silicone leaking into body.The implants are also part of the recall group." later, healthcare professional reported "no event - mri confirmed", but later confirmed left side rupture.Device has been explanted.

• Brand Name: STYLE 20 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: 17775562
• Report Number: 9617229-2023-15073
• Device Sequence Number: 6454707
• Product Code: FTR
• UDI-Device Identifier: 10888628001732
• UDI-Public: 10888628001732
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2023

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: 08/25/2020
• Device Catalogue Number: 20-475
• Device Lot Number: 2802724
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 11/02/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/20/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2015
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 73 KG