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

Catalog Number	NO DEVICE - BREAST
Medical Device Problem Codes	Material Rupture (1546); Malposition of Device (2616); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported ¿rupture¿.Later, healthcare professional reported "animation deformity".This record is for the right side.Device was explanted and replaced.
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 and malposition of device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, g4, h6.
Event or Problem Description
Upon further review, this record is a duplicate.See operative record (b)(4).All the relevant information was transferred to the operative record.
Additional Manufacturer Narrative
Correction to b5 description of event in the previous supplemental medwatch and clarification to h10 related report numbers: it has been identified that this record, mrn, is a duplicate of mrn 9617229-2025-00658.Please see mrn 9617229-2025-00658 for reportable events.
Event or Problem Description
It has been identified that this record, mrn, is a duplicate of mrn 9617229-2025-00658.Please see mrn 9617229-2025-00658 for reportable events.

• 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): ALLERGAN (COSTA RICA); 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: 23478718
• Report Number: 9617229-2025-19025
• Device Sequence Number: 10228770
• Product Code: FTR
• UDI-Device Identifier: 10888628029972
• UDI-Public: (01)10888628029972(10)1255780(11)240730(17)290630
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: NO DEVICE - BREAST
• Device Lot Number: 1255780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/09/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/09/2026
• Date Device Manufactured: 07/30/2024
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White