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); Unspecified Infection (1930)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported rupture.Device remains implanted.
Event or Problem Description
Healthcare professional reported left side rupture.Healthcare professional later reported infection or inflammation (3months) on left side.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: "based on the device analysis grid, the assessments of the complaint are: rupture: observed a broken assessed as an unidentified (tear) opening (shell thickness within spec) and missing shell observed assessed as inconclusive.Additional observations: red particles observed on the device.Red particles observed in the gel.No further actions are required as the device was implanted." additional, corrected and/or changed data: d.9, h.3, h.6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Healthcare professional reported left side rupture.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side rupture.Mri report indicated patient stated experiencing, "an infection or inflammation (3 months) on left breast".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
• 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: 16576475
• Report Number: 9617229-2023-04186
• Device Sequence Number: 14984140
• Product Code: FTR
• UDI-Device Identifier: 10888628003460
• UDI-Public: 10888628003460
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/11/2023

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: 10/01/2022
• Device Model Number: MF-410335
• Device Catalogue Number: MF-410335
• Device Lot Number: 3124871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 05/23/2023; 06/27/2023; Not provided
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/18/2023; 06/12/2023; 07/19/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 66 KG