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

Model Number	TRM-275
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
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.The reason for reoperation is rupture.Reoperation has not been scheduled at this time.
Event or Problem Description
Healthcare professional reported right side rupture and exchange textured to smooth implants due to the patients concern with the product.Device remains implanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r.Has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Device has been explanted and discarded.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Additional, changed, and/or corrected data: b.5, h.6, updated aware date from 10dec2020 to 04mar2021.
Event or Problem Description
Healthcare professional reported right side rupture and exchange textured to smooth implants due to the patients concern with the product.Device has been explanted and discarded.

• 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; CS
• MDR Report Key: 10580305
• Report Number: 9617229-2020-15141
• Device Sequence Number: 2779712
• Product Code: FTR
• UDI-Device Identifier: 10888628008069
• UDI-Public: 10888628008069
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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: 01/15/2022
• Device Model Number: TRM-275
• Device Catalogue Number: TRM-275
• Device Lot Number: 3022711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 03/04/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 04/19/2021; 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR