MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 45 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	45-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30-calendar days from allergan¿s receipt due to the exemption transition period.A review of the device history record has been completed.No deviations or non-conformance's noted.Device evaluation: visual analysis of the returned device identified: broken shell, opening, crease flat and underweight.A microscopic analysis was performed which identify two striated edge opening, consist with use of a surgical tool and a sharp opening in the anterior side.Based on the device analysis the final assessment is two striated edge opening on anterior due to surgical damage and a sharp opening on anterior due to an unidentified (tear) opening.The reason for reoperation is rupture.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported a left side rupture.Device was explanted.

• Brand Name: STYLE 45 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: 8839865
• Report Number: 9617229-2019-04571
• Device Sequence Number: 318453
• Product Code: FTR
• UDI-Device Identifier: 10888628002135
• UDI-Public: 10888628002135
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: P020056
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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: 02/29/2020
• Device Catalogue Number: 45-700
• Device Lot Number: 2721968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 07/29/2019
• 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: 55 YR