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

Catalog Number	TRM-275
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a right-side rupture.Device has been explanted.
Additional Manufacturer Narrative
Asr / psr date submitted: 24jul2017.Visual analysis of the returned device identified: weight to the spec, opening, capsular contracture, crease flat.A microscopic analysis was performed which identify striated edge opening on radius side, consist in the use of some surgical tool.Based on the device analysis the final assessment is: - a striated edge opening on radius side due to surgical damage.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.
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 17/apr/2017 and 24/jul/2017.Additional, changed, and/or corrected data: a4, a5, a6, b2, b5, b6, d9, h3, h6, h11.
Event or Problem Description
Healthcare professional reported a right-side rupture.Healthcare professional later reported right side "intact textured silicone implant was encountered" and "no sign of rupture or leak" observed during surgery.Device has been explanted and replaced.

• Brand Name: INSPIRA TEXTURED 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: 21866653
• Report Number: 9617229-2025-06445
• Device Sequence Number: 17320681
• Product Code: FTR
• UDI-Device Identifier: 10888628008069
• UDI-Public: (01)10888628008069(10)2890562(11)160401(17)210301
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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 Expiration Date: 03/01/2021
• Device Catalogue Number: TRM-275
• Device Lot Number: 2890562
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2016
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White