MAUDE Adverse Event Report: UNKNOWN ALLERGAN INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	TSF-295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture".This is for the left side.Device was explanted and not replaced.
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.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): UNKNOWN ALLERGAN; 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22498413
• Report Number: 9617229-2025-11732
• Device Sequence Number: 15606944
• Product Code: FTR
• UDI-Device Identifier: 10888628034105
• UDI-Public: (01)10888628034105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: TSF-295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/14/2025
• 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: 38 YR
• Patient Sex: Female