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

Model Number	115-222
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side rupture.Device remains implanted.
Additional Manufacturer Narrative
Explant date: explant date was provided before the date of surgery , with no proof of explant the device status remains implanted.Device history record is not available due to insufficient device data.Further information from the reporter regarding event, product, or patient details will be requested.No additional information is available at this time.The reason for reoperation is: rupture.
Event or Problem Description
The patient underwent a capsulectomy.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 photo analysis: visual analysis of the photographs identified: rupture: no observe openings.It is not possible to determine the lot number or catalog through the photos provided.
Event or Problem Description
The device has been explanted and replaced.
Event or Problem Description
Patient reported left side rupture.The patient underwent a capsulectomy.The 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 assessed as an unidentified (tear) opening and missing shell assessed as inconclusive.Anxiety-product/procedure: unable to observe as it is a medical event not related to the device.And missing shell assessed as inconclusive.Additional observations: red particles observed on the device.No further actions are required as the device was implanted.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.

• 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: 16206121
• Report Number: 9617229-2023-00552
• Device Sequence Number: 20197268
• Product Code: FTR
• UDI-Device Identifier: 10888628002340
• UDI-Public: 10888628002340
• 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: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2023
• 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: 01/27/2020
• Device Model Number: 115-222
• Device Catalogue Number: 115-222
• Device Lot Number: 2711059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/27/2023; 03/07/2023; 04/29/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/16/2023; 03/29/2023; 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2015
• 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: 51 YR
• Patient Sex: Female