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

Catalog Number	SRM-600
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture".This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
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.
Event or Problem Description
Healthcare professional reported left side rupture and "hole non-specific." device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4; b5; b6; d6b; h6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h.3, h.6 device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture: observed broken device assessed as unidentified (tear) opening.A workmanship was observed not related to the complaint for a split in patch observed event.A further investigation is requested to analyze the split in patch observed.As per the investigation procedure, creases were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Healthcare professional reported "rupture".Healthcare professional reported "ruptured implant after car accident".This record is for the left side.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: b5, d4, d9, h3, h4, h6.
Event or Problem Description
Healthcare professional reported "rupture".Healthcare professional later reported left side rupture and "hole non-specific." healthcare professional later reported "ruptured implant after car accident".Device has been explanted.
Additional Manufacturer Narrative
Further investigation: the review of the documentation associated to the manufacturing process indicates that all devices involved in this work order were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the device analysis performed in the laboratory was observed split (ss) in patch area, it is out of specification per qa199.04.The event of rupture was observed, therefore, the reported event was confirmed, however, this workmanship has not relation to reported complaint.A review of the current risk documents pfmea-silicone filled bi and sizer assy rev.8.0 was performed, and the event of split in patch is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with split in patch will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported left side rupture.The device has been explanted.

• 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: 21874082
• Report Number: 9617229-2025-06528
• Device Sequence Number: 15420087
• Product Code: FTR
• UDI-Device Identifier: 10888628007185
• UDI-Public: (01)10888628007185(10)2949139(11)160823(17)210723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 07/23/2021
• Device Catalogue Number: SRM-600
• Device Lot Number: 2949139
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/28/2025; 09/22/2025; 10/08/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/15/2025; 10/02/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2016
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 80 KG