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

Catalog Number	SSX-340
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Dhr trend summary: the review of all potential trend evaluations for breast implants closed during the past 12 months indicates that no confirmed complaint trends have been observed for the event a020602 component missing.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: packaging error (component missing).
Event or Problem Description
Company representative reported "implant was opened and did not have a fill tube in it".This record is for left side.Device was not implanted.

• 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 ; 8479366324
• MDR Report Key: 22040614
• Report Number: 9617229-2025-08132
• Device Sequence Number: 13035433
• Product Code: FTR
• UDI-Device Identifier: 10888628033313
• UDI-Public: (01)10888628033313(10)1195784(11)230706(17)280606
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SSX-340
• Device Lot Number: 1195784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 07/06/2023
• 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
• Patient Sex: Unknown