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

Model Number	TRM-755
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/10/2020
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.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 right-side rupture.Device remains implanted.
Event or Problem Description
Healthcare professional reported right-side rupture and exchange from a textured to smooth breast implant due to the patient¿s concern with the product.Device remains implanted.
Event or Problem Description
The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5., b.6., d6b., h.6.
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.¿ rupture: no observed rupture on the device.Additional observations: ¿ deformation device, crease fold, wear abrasion and yellow biological tissue observed on the device.Additional, changed, and/or corrected data: d9, h3, h6.
Event or Problem Description
Healthcare professional reported right-side rupture and exchange from a textured to smooth breast implant due to the patient¿s concern with 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 10979218
• Report Number: 9617229-2020-20211
• Device Sequence Number: 702841
• Product Code: FTR
• UDI-Device Identifier: 10888628008212
• UDI-Public: 10888628008212
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/31/2023

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: 01/13/2021
• Device Model Number: TRM-755
• Device Catalogue Number: TRM-755
• Device Lot Number: 2868742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 03/21/2023; 04/26/2023; 07/08/2023
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 04/06/2023; 05/15/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2016
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 118 KG