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

Model Number	TRM-405
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformance's noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation is: "left implant rupture found on ct scan".
Event or Problem Description
Healthcare provider reported a left side rupture found on ct scan and textured implant recall.The device has been explanted and replaced.
Event or Problem Description
Healthcare provider reported a left side rupture found on ct scan and textured implant recall.The device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: was observed, broken device on posterior side assessed, as surgical impact opening (shell thickness within specification).Anxiety-product/procedure: unable to observe, as it is a medical event.That is not related to the device.Additional observations: black particles on the shell are observed.Non penetrating nick is observed, assessed as non-penetrating nick.No further actions are required, as the device was implanted.
Event or Problem Description
Healthcare provider reported, a left side rupture, found on ct scan.And textured implant recall.The 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: 15195548
• Report Number: 9617229-2022-13221
• Device Sequence Number: 5634303
• Product Code: FTR
• UDI-Device Identifier: 10888628008137
• UDI-Public: 10888628008137
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2022

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: 01/18/2021
• Device Model Number: TRM-405
• Device Catalogue Number: TRM-405
• Device Lot Number: 2872665
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 09/08/2022; 10/19/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/04/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2016
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 64 KG