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

Model Number	110-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported a right side rupture confirmed via mri.The non-device related event of "malignant neoplasm of breast unknown" was reported.The device has been explanted, replaced and a capsulectomy was performed.
Additional Manufacturer Narrative
Continued h6: f2203.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.The reason for reoperation is: rupture.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Photo analysis: visual analysis of the photographs identified: rupture : observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.It is not possible to determine the lot number or catalog through the photos provided.
Event or Problem Description
Patient reported a right side rupture confirmed via mri.The non-device related event of "malignant neoplasm of breast unknown" was reported.The device has been explanted, replaced and a capsulectomy was performed.
Event or Problem Description
Patient reported a right side rupture confirmed via mri.The non-device related event of "malignant neoplasm of breast unknown" was reported.The device has been explanted, replaced and a capsulectomy was performed.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture: observed broken on posterior side assessed as unidentified (tear) opening and missing piece of shell assessed as inconclusive.(shell thickness within specification).¿ cancer breast-ndr: not applicable as the event is not related to the device.Additional observations: ¿ observed wear abrasion on the device.

• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16979946
• Report Number: 9617229-2023-08716
• Device Sequence Number: 12382239
• Product Code: FTR
• UDI-Device Identifier: 10888628002173
• UDI-Public: 10888628002173
• 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,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023
• 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: 01/15/2023
• Device Model Number: 110-150
• Device Catalogue Number: 110-150
• Device Lot Number: 3167370
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 08/22/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/12/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2018
• 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: 60 YR
• Patient Sex: Female
• Patient Race: Asian