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

Model Number	SSLP-360
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
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
Healthcare professional reported left side rupture.Device remains implanted.
Additional Manufacturer Narrative
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.Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: not observed, capsular contracture : unable to observe since it is a medical event and is not related to the device.Additional observations: deformation observed.Crease flat observed.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional later reported left side capsular contracture baker grade unknown via dt form.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: not observed, additional observations: deformation observed.Crease flat observed.
Event or Problem Description
An mri confirmed left side rupture.The device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (AUSTIN); 12331-a riata trace parkway; building 3; austin TX 78727
• Manufacturer (Section G): ALLERGAN (AUSTIN); 12331-a riata trace parkway; building 3; austin TX 78727
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16251158
• Report Number: 9617229-2023-00651
• Device Sequence Number: 14802484
• Product Code: FTR
• UDI-Device Identifier: 10888628032767
• UDI-Public: 10888628032767
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2023

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: 11/03/2025
• Device Model Number: SSLP-360
• Device Catalogue Number: SSLP-360
• Device Lot Number: 3479593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/30/2023; 02/20/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/20/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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: 64 KG