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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance noted.Reason for reoperation: rupture.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported right side rupture.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified; broken shell and others and underweight.A visual and microscopic analysis was performed which identified; sharp break on posterior and sharp opening on posterior.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 break on posterior assessed as an unidentified (tear) opening.A sharp opening on posterior assessed as an unidentified (tear) opening.Additional, changed, and/or corrected data.
Event or Problem Description
Healthcare professional reported right side rupture.The device has been explanted.

• 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; CS
• MDR Report Key: 9219197
• Report Number: 9617229-2019-16779
• Device Sequence Number: 2145615
• Product Code: FTR
• UDI-Device Identifier: 10888628002197
• UDI-Public: 10888628002197
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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: 10/30/2020
• Device Model Number: 110-210
• Device Catalogue Number: 110-210
• Device Lot Number: 2837125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 07/01/2020
• 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