MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MX-410370
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side rupture and exchange from textured to smooth due to concern with the product.Healthcare professional later reported "discoloration around skin in upper and outer quadrant - unknown if related to device." device remains implanted.
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, anxiety-product/procedure, visibility/palpability.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Patient reported left side rupture and exchange from textured to smooth due to concern with the product.Healthcare professional later reported left side "discoloration around skin in upper and outer quadrant - unknown if related to device".Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Visibility/palpability: unable to observe as it is a medical event not related to the device.Rupture: no observed openings on the device.Additional observations: crease fold, deformation and wear abrasion observed on the device.White particles observed on the device.No further actions are required as the device was implanted.

• Brand Name: STYLE 410 COHESIVE 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: 16452712
• Report Number: 9617229-2023-02892
• Device Sequence Number: 17603353
• Product Code: FTR
• UDI-Device Identifier: 10888628003736
• UDI-Public: 10888628003736
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2023

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: 04/13/2020
• Device Model Number: MX-410370
• Device Catalogue Number: MX-410370
• Device Lot Number: 2740453
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 06/14/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/30/2023; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2015
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 54 KG