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

Catalog Number	SCM-210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 ¿rupture¿ via ultrasound.Later, healthcare professional reported "rupture" and "pain".This record is for the right side.Device was explanted and replaced with another manufacturer's device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.1., d.2a., d.2b., d.4., h.6.
Event or Problem Description
Healthcare professional reported ¿rupture¿ via ultrasound.Later, healthcare professional reported "rupture" and "pain".This record is for the right side.Device was explanted and replaced with another manufacturer's device.
Event or Problem Description
Healthcare professional reported ¿rupture¿ via ultrasound.Later, healthcare professional reported "rupture" and "pain".This record is for the right side.Device was explanted and replaced with another manufacturer's device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: 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 broken device through microscopic inspection assessed as unidentified (tear) opening and missing piece of shell assessed as inconclusive.No further actions are required as it is not related to the manufacturing process.Breast pain: unable to observe through visual inspection as it is a physiological phenomenon.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 COHESIVE 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): UNKNOWN ALLERGAN; 900 parkway global park zona f; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23526416
• Report Number: 9617229-2025-19488
• Device Sequence Number: 9084241
• Product Code: FTR
• UDI-Device Identifier: 10888628029828
• UDI-Public: (01)10888628029828
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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: SCM-210
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/02/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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