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

Model Number	SCL-320
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2020
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.
Event or Problem Description
Patient reported left side rupture.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data:: b5, g2.
Event or Problem Description
Patient reported left side rupture.Healthcare professional additionally reported "any creases." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified; fold creases.Deformation, the weight the device within specification.After autoclave cycle was observed: cloudy gel.Based on the device analysis the final assessment is: no openings found.Fold creases.
Event or Problem Description
Patient reported left side rupture.Healthcare professional additionally reported "any creases." device has been explanted.

• 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; CS
• MDR Report Key: 10706868
• Report Number: 9617229-2020-16832
• Device Sequence Number: 2953914
• Product Code: FTR
• UDI-Device Identifier: 10888628029514
• UDI-Public: 10888628029514
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2021

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: 05/26/2022
• Device Model Number: SCL-320
• Device Catalogue Number: SCL-320
• Device Lot Number: 3070578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 12/18/2020; 02/04/2021; 03/02/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/14/2021; 03/04/2021; 04/01/2021
• 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: 38 YR