MAUDE Adverse Event Report: Allergan (Costa Rica) Inspira Smooth Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SRM-310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "exchange with no complaint against the device".Later healthcare professional reported "fractured implant" which was discovered during surgery.The device has been explanted.
Event or Problem Description
Healthcare professional reported "exchange with no complaint against the device".Later healthcare professional reported "fractured implant".Later healthcare professional "neither implant was ruptured" and "broken gel".This record is for the left side.Device has been explanted.Singulair was prescribed for contralateral side capsular contracture.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Continued e1 -- alternate phone number:(b)(6).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: removal due to contralateral side capsular contracture and rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d9, h3, h6.Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: - rupture: observed an opening through microscopic inspection assessed as surgical damage.No further actions are required as it is not related to the manufacturing process.None of the other observations performed during the device analysis creases are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.

• Brand Name: Inspira Smooth 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; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50234459
• Report Number: 9617229-2026-15243
• Device Sequence Number: 10256849
• Product Code: FTR
• UDI-Device Identifier: 10888628007086
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SRM-310
• Device Lot Number: 1246918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/13/2026
• Date Device Manufactured: 06/03/2024
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 112 LB
• Patient Race: White