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

Model Number	TRL-350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
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: rupture.
Event or Problem Description
Patient reported left side there was a "leak" in the implant.Additionally, healthcare professional reported left side rupture and implant exchange from textured to smooth due to the patient's concern of the product.Device remains implanted.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Healthcare professional additionally reported left side pain.
Event or Problem Description
Patient reported left side there was a "leak" and implant exchange from textured to smooth due to the patient's concern of the product.Healthcare professional additionally reported left side rupture, implant exchange from due to concern with "textured" product, and confirmed there was no "pain." device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified black mold like appearance (60%), an extended opening, flat creases.The device was found to be underweight.A microscopic analysis was performed which identified an extended sharp opening on the posterior side assessed as an unidentified(tear) opening.A dimension measurement of the shell was performed which identified the thickness to be within specification.Based on the device analysis the final assessment is a sharp opening assessed as an unidentified (tear) opening.

• 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: 10467451
• Report Number: 9617229-2020-13694
• Device Sequence Number: 2476176
• Product Code: FTR
• UDI-Device Identifier: 10888628007734
• UDI-Public: 10888628007734
• Combination Product (Y/N): N
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/14/2021

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: 06/04/2020
• Device Model Number: TRL-350
• Device Catalogue Number: TRL-350
• Device Lot Number: 2766684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 12/18/2020; 01/28/2021; 03/18/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 01/14/2021; 02/26/2021; 04/14/2021
• 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