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

Model Number	FM-410500
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 and pain.Device remains implanted.
Event or Problem Description
Healthcare professional "implant folds with small amount of silicone seen on both sides of the radial fold." the device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: crease flat, opening, brown particles and underweight.A microscopic analysis was performed which identify sharp edge opening in the same edge assessed as unidentified tear opening.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 opening on anterior due to an unidentified (tear) opening.Additional, changed, and/or corrected data: d.10, g.4, h.3, h.6.
Event or Problem Description
Patient reported left side rupture and pain.Healthcare professional additionally reported "implant folds with small amount of silicone seen on both sides of the radial fold." 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; CS
• MDR Report Key: 9758498
• Report Number: 9617229-2020-02509
• Device Sequence Number: 2650150
• Product Code: FTR
• UDI-Device Identifier: 10888628002883
• UDI-Public: 10888628002883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

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: 09/26/2022
• Device Model Number: FM-410500
• Device Catalogue Number: FM-410500
• Device Lot Number: 3122168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 05/22/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/23/2020; 06/18/2020
• 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 Weight: 52