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

Model Number	TRM-295
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 allergan is not requesting the device return at this time due to global safety concerns associated with covid-19.
Event or Problem Description
Healthcare professional reported a right side rupture.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified a broken shell, missing shell, and underweight device.A visual and microscopic analysis were performed which identified a sharp break on the posterior side assessed as a surgical impact opening, and stress mark on the shell.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis, the final assessment is a sharp break on the posterior side assessed as a surgical damage openings and missing shell assessed as inconclusive.Additional, corrected, and/or changed data: b.5., d.6b., d.9., h.3., h.6.
Event or Problem Description
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; CS
• MDR Report Key: 10151377
• Report Number: 9617229-2020-08845
• Device Sequence Number: 2094977
• Product Code: FTR
• UDI-Device Identifier: 10888628008076
• UDI-Public: 10888628008076
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2020

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: 12/22/2020
• Device Model Number: TRM-295
• Device Catalogue Number: TRM-295
• Device Lot Number: 2858005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/13/2020
• Supplement Report FDA Received Date: 06/09/2021
• 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