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

Catalog Number	110-120
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient reported left side suspected rupture.The device remains implanted.
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.
Event or Problem Description
The device has been explanted and replaced.
Additional Manufacturer Narrative
Visual analysis of the photographs identified: rupture: observed, but cannot perform an assessment of the opening, as no microscopic analysis can be performed.No additional observations were carried out.No further actions are required, as no manufacturing issues are observed.
Event or Problem Description
Patient reported, left side suspected rupture.The device has been explanted and replaced.
Event or Problem Description
Patient reported left side suspected rupture.The device has been explanted and replaced.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture : observed, opening assessed as unidentified (tear) opening.(shell thickness was within specification).No additional observation.No further actions are required as no issues with the manufacturing process are observed.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18204915
• Report Number: 9617229-2023-19501
• Device Sequence Number: 6367380
• Product Code: FTR
• UDI-Device Identifier: 10888628002166
• UDI-Public: 10888628002166
• 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: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2021
• Device Catalogue Number: 110-120
• Device Lot Number: 2889631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: Not provided; 02/13/2024; 03/19/2024
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 12/31/2023; 02/26/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2016
• 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: 52 YR
• Patient Sex: Female