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

Model Number	TRM-330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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 was rupture.
Event or Problem Description
Healthcare professional reported left side implant exchange from textured to smooth due to patient's concern with the device.Healthcare professional additionally reported left side rupture.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side implant exchange from textured to smooth due to patient's concern with the device.Healthcare professional additionally reported left side rupture.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified to be underweight, an opening, and a missing piece of the shell.A microscopic analysis was performed which identified a sharp edge broken assessed as unidentified tear broken and a missing piece of the shell.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a broken sharp in the posterior side assessed as unidentified (tear) opening.Missing piece of the shell 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: 11636172
• Report Number: 9617229-2021-06552
• Device Sequence Number: 3546639
• Product Code: FTR
• UDI-Device Identifier: 10888628008090
• UDI-Public: 10888628008090
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 01/27/2021
• Device Model Number: TRM-330
• Device Catalogue Number: TRM-330
• Device Lot Number: 2875240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/18/2021
• 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: 52 YR
• Patient Weight: 57