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

Model Number	SCX-400
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance noted.The event of "capsular contracture" 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.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a.4, a.6, b.5, d.6b, d.9, h.3, h.6.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, the weight the device within specification, fold creases, and wear abrasion.After autoclave cycle was observed: cloudy color in the gel.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.

• Brand Name: INSPIRA SMOOTH COHESIVE 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: 11343816
• Report Number: 9617229-2021-01285
• Device Sequence Number: 17351295
• Product Code: FTR
• UDI-Device Identifier: 10888628030299
• UDI-Public: 10888628030299
• 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: 2020
• 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): 03/19/2021

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: 01/05/2025
• Device Model Number: SCX-400
• Device Catalogue Number: SCX-400
• Device Lot Number: 3412070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 03/19/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/19/2021; 04/16/2021
• 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: 65 YR
• Patient Weight: 45