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

Model Number	TRF-745
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "infection (unknown onset)" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: infection (unknown onset).
Event or Problem Description
Healthcare professional reported right side infection and implant removal from textured to smooth due to the concerns of the product.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Infection (late onset): unable to observe as it is a medical event not related to the device.Additional observations: yellow particles observed on the device.Crease flat observed on the device.Wear abrasion observed on the device.Observed split in patch area, it is out of specification per qa 199.04 assessed as a workmanship.Further investigation: during the trend review of all infection complaints for gel breast implants for the period of dec-2020 through nov-2022, were noted an outliers in jan-2021 and mar-2021.An additional analysis was performed to determine any pattern or any similarities relation between prs involved.It was found that some primary packaging operators were involved in more than one occasion, however the people were trained in the corresponding procedure.Also, it was found a sealer and a sterilizer involved in more than one occasion on those processes, also, calibrations and maintenance of the equipment¿s involved in more than one occasion were reviewed and it was determined that they were performed on time and met specifications.In addition, all the records involved in this month were reviewed and no issues were found associated to either event.Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event, and no er/ ncr(s) or temporary changes were identified during the investigation associated to this lot and the complaint, no corrective action is deemed necessary at this time.
Event or Problem Description
Healthcare professional reported right side infection and implant removal from textured to smooth due to the concerns of the product.The device has been explanted.

• Brand Name: INSPIRA TEXTURED 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: 16098767
• Report Number: 9617229-2022-23445
• Device Sequence Number: 6610037
• Product Code: FTR
• UDI-Device Identifier: 10888628008410
• UDI-Public: 10888628008410
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 01/03/2021
• Device Model Number: TRF-745
• Device Catalogue Number: TRF-745
• Device Lot Number: 2864903
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2016
• 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 Sex: Female
• Patient Weight: 61 KG