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

Catalog Number	SCX-545
Medical Device Problem Codes	Break (1069); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
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: break and device handling problem.
Event or Problem Description
Healthcare professional reported "implant punctured during a procedure.The device did not come into contact with the patient".Later healthcare professional reported implant shell had the problem and the device had contact with patient.This record is for the right side.Device was explanted.
Event or Problem Description
Healthcare professional reported "implant punctured during a procedure.The device did not come into contact with the patient".Later healthcare professional reported implant shell had the problem and the device had contact with patient.This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported events broken device, use error was received on dec 16, 2025 with lot number 1262351.Per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ broken device: not observed through visual inspection.¿ use error: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (deformation, 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): 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: 22093310
• Report Number: 9617229-2025-08719
• Device Sequence Number: 6936013
• Product Code: FTR
• UDI-Device Identifier: 10888628030350
• UDI-Public: (01)10888628030350(10)1262351(11)240906(17)290806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: SCX-545
• Device Lot Number: 1262351
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White