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-410445
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The event of seroma 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: rupture and patients concern with product.
Event or Problem Description
Healthcare professional reported left side "rupture and exchange from textured to smooth breast implant due to the patient¿s concern with the product".Healthcare professional additionally reported "a rent in the capsule was made demonstrating approximately 20cc of cloudy seroma." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: one extended opening and yellow particles material was found on the shell.A weight test of the device was verified and the device underweight.A microscopic analysis was performed which identified one opening extended sharp and partial delamination of orientation dot.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp edge opening in the side posterior assessed as unidentified (tear) opening.Partial delamination of orientation dot assessed as adhesive failure.
Event or Problem Description
Healthcare professional reported left side "rupture and exchange from textured to smooth breast implant due to the patient¿s concern with the product".Healthcare professional additionally reported "a rent in the capsule was made demonstrating approximately 20cc of cloudy seroma." device has been explanted.

• 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
• MDR Report Key: 12169815
• Report Number: 9617229-2021-47507
• Device Sequence Number: 3819889
• Product Code: FTR
• UDI-Device Identifier: 10888628003750
• UDI-Public: 10888628003750
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 12/15/2020
• Device Model Number: MX-410445
• Device Catalogue Number: MX-410445
• Device Lot Number: 2854566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 75