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

Catalog Number	SRX-420
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side "dropped".The device remains implanted.
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: malposition of device.
Event or Problem Description
Patient reported left side "dropped".The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b3 h6 h11 clarification to partial date of occurrence b3: "a couple months ago" was provided.The following reported event(s) is a/are physiological complication(s), and device analysis typically does not help allergan determine the cause: malposition.

• 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: 22781297
• Report Number: 9617229-2025-13588
• Device Sequence Number: 18201967
• Product Code: FTR
• UDI-Device Identifier: 10888628007512
• UDI-Public: (01)10888628007512(10)3088922(11)170807(17)220707
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2022
• Device Catalogue Number: SRX-420
• Device Lot Number: 3088922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 08/07/2017
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White