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

Model Number	TRM-600
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	05/09/2020
Type of Reportable Event	Serious Injury
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.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 left side "rupture per mammogram" and implant exchange due to patient's concern of the product.Device remains implanted.
Additional Manufacturer Narrative
The event of capsular contracture is a physiological complication.And analysis of the device generally does not assist allergan in determining a probable cause for this event.Additional, changed and/or corrected data: capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional, later reported, capsular contracture, baker grade iii.
Event or Problem Description
The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe, since it is not related to the device.Anxiety-product/procedure: unable to observe, since it is not related to the device.Rupture: observed, broken on posterior side assessed, as surgical impact opening.And missing piece of shell assessed, as inconclusive.Shell thickness within specification.Additional observations: observed, non penetrating nick on the device.No further actions are required, as the device was implanted.
Event or Problem Description
Healthcare professional reported, left side "rupture.Per mammogram".And implant exchange, due to patient's concern 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: 16781801
• Report Number: 9617229-2023-06509
• Device Sequence Number: 15130746
• Product Code: FTR
• UDI-Device Identifier: 10888628008182
• UDI-Public: 10888628008182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2024

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: 02/05/2021
• Device Model Number: TRM-600
• Device Catalogue Number: TRM-600
• Device Lot Number: 2878369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 01/18/2024; 03/12/2024
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 12/05/2023; 01/29/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2016
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 68 KG