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

Model Number	TRF-265
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
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "capsular contracture, baker grade iii-iv" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: "capsular contracture, baker grade iii-iv.".
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii-iv.The device remains implanted.
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.
Event or Problem Description
Healthcare professional additionally reported a hole, non-specific and "ruptured." the device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii-iv.Healthcare professional additionally reported a hole, non-specific and "ruptured." the device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: underweight and broken shell.A visual and microscopic analysis was performed which identified: sharp broken on posterior and wear abrasion.A dimension measurement in the shell was performed which identify the thickness within specification based on the device analysis the final assessment is: a sharp broken on posterior 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
• MDR Report Key: 12024912
• Report Number: 9617229-2021-07443
• Device Sequence Number: 3404024
• Product Code: FTR
• UDI-Device Identifier: 10888628008267
• UDI-Public: 10888628008267
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 09/08/2021

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: 01/01/2021
• Device Model Number: TRF-265
• Device Catalogue Number: TRF-265
• Device Lot Number: 2864897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 08/10/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/28/2021; 09/08/2021
• 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