MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	115-185
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect-f15 recognized device or procedural complication; f2201-biopsy a review of the device history record has been completed.No deviations or non-conformances noted.Photo analysis: visual analysis of the photos identified: rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.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
Healthcare professional reported left side rupture.Device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported left side rupture.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed a broken sharp assessed as unidentified (tear) opening (shell thickness was within specification) and missed piece of the shell assessed as to inconclusive.Additional observations: brown particles observed in the surface of the shell.Crease flat observed in the device.Wear abrasion observed in the device.No further actions are required as the device was implanted.

• Brand Name: STYLE 115 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16549689
• Report Number: 9617229-2023-03602
• Device Sequence Number: 15075625
• Product Code: FTR
• UDI-Device Identifier: 10888628002326
• UDI-Public: 10888628002326
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 06/28/2022
• Device Model Number: 115-185
• Device Catalogue Number: 115-185
• Device Lot Number: 3087051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female