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

Model Number	TRF-365
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/20/2021
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.Reason for reoperation: exchange from textured to smooth breast implants due to the patient¿s concern with the product and rupture.
Event or Problem Description
Healthcare professional reported right side "exchange from textured to smooth breast implants due to the patient¿s concern with the product" and ¿right-side rupture, confirmed during surgery.¿ device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: broken shell, underweight.A microscopic analysis was performed which identified: broken shell with sharp edge where is localized stresses induced in posterior side assessed as surgical impact(a dimension measurement in the shell was performed which identify the thickness within specification), non penetrating nicks and broken shell with striated edge on radius side assessed as surgical damage consist in the use of some surgical tool.Based on the device analysis the final assessment is: broken shell with sharp edge where is localized stresses induced assessed as surgical impact.Broken shell with striated edge assessed as surgical damage consist in the use of some surgical tool.
Event or Problem Description
Healthcare professional reported right side "exchange from textured to smooth breast implants due to the patient¿s concern with the product" and ¿right-side rupture, confirmed during surgery.¿ device has been explanted.

• 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
• MDR Report Key: 12025967
• Report Number: 9617229-2021-07576
• Device Sequence Number: 11850653
• Product Code: FTR
• UDI-Device Identifier: 10888628008311
• UDI-Public: 10888628008311
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 02/14/2021
• Device Model Number: TRF-365
• Device Catalogue Number: TRF-365
• Device Lot Number: 2884971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: 44 YR