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

Model Number	TRL-290
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/04/2020
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.Reason for reoperation: rupture.
Event or Problem Description
Patient reported left side rupture.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed and/or corrected data: b.5., b.6., d.6b., g.2., h.6.
Event or Problem Description
Patient reported left side rupture.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: broken shell, underweight, yellow particles in shell, flat creases, around 0-25% of the shell is missing.A microscopic analysis was performed which identified: an extended sharp opening on posterior side assessed as unidentified(tear) opening(a dimension measurement in the shell was performed which identify the thickness within specification), 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) and wear abrasion.Based on the device analysis the final assessment is: a sharp opening assessed as unidentified (tear) opening.Broken shell with sharp edge where is localized stresses induced assessed as surgical impact.Missing shell that is assessed as inconclusive.

• 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: 11104961
• Report Number: 9617229-2020-21700
• Device Sequence Number: 3711275
• Product Code: FTR
• UDI-Device Identifier: 10888628007710
• UDI-Public: 10888628007710
• Combination Product (Y/N): N
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2021

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: 01/13/2021
• Device Model Number: TRL-290
• Device Catalogue Number: TRL-290
• Device Lot Number: 2868702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/15/2021; 03/23/2021
• Initial Report FDA Received Date: 01/02/2021
• Supplement Report FDA Received Date: 03/15/2021; 04/21/2021
• 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: 53 YR