MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2021
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: intracapsular rupture" and "partial double capsule" and exchange due to patient product concern.
Event or Problem Description
Healthcare professional reported left side exchange from textured to smooth implanted due to the patient's concern with the product.Healthcare professional reported "intracapsular rupture" and "partial double capsule".Device has been explanted.
Event or Problem Description
Healthcare professional reported left side exchange from textured to smooth implanted due to the patient's concern with the product.Healthcare professional reported "intracapsular rupture" and "partial double capsule." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: broken shell and underweight.A visual and microscopic analysis was performed which identified: broken crease sharp on radius, creases fold and missing shell.Base on the device analysis the final assessment is: a broken crease sharp on radius assessed as fold flaw opening.Missing shell assessed as inconclusive.

• Brand Name: STYLE 110 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: 11757922
• Report Number: 9617229-2021-07082
• Device Sequence Number: 3191973
• Product Code: FTR
• UDI-Device Identifier: 10888628002197
• UDI-Public: 10888628002197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 04/27/2020
• Device Model Number: 110-210
• Device Catalogue Number: 110-210
• Device Lot Number: 2747317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: 60 YR
• Patient Weight: 57