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

Model Number	MF-410335
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	12/29/2020
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.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
Healthcare professional reported a left side rupture and an exchange from textured to smooth due to concern with the products.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a.4.
Event or Problem Description
Healthcare professional reported a left side rupture and an exchange from textured to smooth due to concern with the products.Device has been explanted.
Event or Problem Description
Healthcare professional additionally reported a left side "swollen breast" and "fluid around the implant.".
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: yellow particles on the surface of the shell, weight to the specification, and deformation.Cloudy gel observed after the autoclave disinfection process.Based on the device analysis the final assessment is: no issues found related with the manufacturing process and no openings or issues related to rupture device were observed.

• 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: 11286311
• Report Number: 9617229-2021-00458
• Device Sequence Number: 14321546
• Product Code: FTR
• UDI-Device Identifier: 10888628003460
• UDI-Public: 10888628003460
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/24/2021

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: 05/26/2023
• Device Model Number: MF-410335
• Device Catalogue Number: MF-410335
• Device Lot Number: 3220467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 03/17/2021; 04/28/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/16/2021; 04/15/2021; 05/24/2021
• 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: 39 YR
• Patient Weight: 57