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

Model Number	TRX-310
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "concern's of the product" and "capsular contracture baker grade unknown" against right device.The device remains implanted.
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.The event of capsular contracture baker grade unknown is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reason for reoperation is capsular contracture baker grade unknown.Reoperation has not been scheduled at this time.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a5a, a.6, b.5, d.6b, h.6.
Event or Problem Description
Healthcare professional additionally reported rupture.The device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: weight to the spec, crease fold and deformation.Cloudy was observed after autoclave disinfection process.No openings observed in the device.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Healthcare professional reported "concern's of the product" and "capsular contracture baker grade unknown" and rupture against right device.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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12839833
• Report Number: 9617229-2021-56656
• Device Sequence Number: 4353617
• Product Code: FTR
• UDI-Device Identifier: 10888628008472
• UDI-Public: 10888628008472
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022

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: 08/17/2020
• Device Model Number: TRX-310
• Device Catalogue Number: TRX-310
• Device Lot Number: 2805799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 12/22/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/10/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic