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

Catalog Number	SRLP-320
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Company representative reported unknown side rupture.Device has been explanted.
Event or Problem Description
Company representative reported right side rupture.Device has been explanted and replaced with non-allergan device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d6a.
Event or Problem Description
Company representative reported right side rupture.Device has been explanted and replaced.
Event or Problem Description
Company representative reported, unknown side rupture.Device has been explanted.
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.Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed, broken on posterior side assessed, as unidentified (tear) and missing piece of shell assessed, as inconclusive.Shell thickness within specification additional observations: no other observations observed.No further actions are required, as the device was implanted.
Additional Manufacturer Narrative
Changed, and/or corrected data: d4 the previously reported device info.Does not belong to record or patient and will be un-reported.
Event or Problem Description
Healthcare professional reported right 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 (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18584971
• Report Number: 9617229-2024-01472
• Device Sequence Number: 6016173
• Product Code: FTR
• UDI-Device Identifier: 10888628006911
• UDI-Public: 10888628006911
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 07/24/2023
• Device Catalogue Number: SRLP-320
• Device Lot Number: 3231550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/23/2024; 03/19/2024; 04/19/2024; 06/26/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/19/2024; 04/11/2024; 05/13/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Race: White