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-410470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2019
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 and "bilateral deformities, pain and implants had flipped.".
Event or Problem Description
Healthcare professional reported a left side rupture and "bilateral deformities, pain and implants had flipped".Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a.4, g.1.
Event or Problem Description
Healthcare professional reported a left side rupture and "bilateral deformities, pain and implants had flipped." 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: 9611673
• Report Number: 9617229-2020-00326
• Device Sequence Number: 2669357
• Product Code: FTR
• UDI-Device Identifier: 10888628003491
• UDI-Public: 10888628003491
• Combination Product (Y/N): N
• Initial Reporter State: NM
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 06/14/2020
• Device Model Number: MF-410470
• Device Catalogue Number: MF-410470
• Device Lot Number: 2777070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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 Age: 37 YR
• Patient Weight: 57