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

Catalog Number	TRM-345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side exchange due to recall with no complaint.Healthcare professional later reported left rupture and "textured implant".Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.Reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported left side exchange due to recall with no complaint.Healthcare professional later reported left rupture and "textured implant".Patient additionally reported "pain." device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Patient additionally reported "pain.".
Event or Problem Description
Healthcare professional later reported "hole, non-specific." device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.
Additional Manufacturer Narrative
Clarification to d9: only device photos were received.Visual analysis: visual analysis of the photographs identified, rupture: observed.But, cannot perform an assessment of the opening, as no microscopic analysis can be performed.Pain: unable to observe, as it is not related to the device.Anxiety-product/procedure: unable to observe, as it is not related to the device.No additional observations.No further actions are required, as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported, left side exchange, due to recall with no complaint.Healthcare professional, later reported, left rupture and "textured implant".Patient additionally reported, "pain." healthcare professional, later reported, "hole, non-specific".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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18421334
• Report Number: 9617229-2023-19988
• Device Sequence Number: 15176812
• Product Code: FTR
• UDI-Device Identifier: 10888628008106
• UDI-Public: 10888628008106
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/11/2024

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: 09/13/2021
• Device Catalogue Number: TRM-345
• Device Lot Number: 2973894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 01/19/2024; 02/07/2024; 03/04/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/17/2024; 01/23/2024; 02/12/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2016
• 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 Sex: Female
• Patient Weight: 70 KG