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

Model Number	SCF-695
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.The reason for reoperation: "implant ruptured when putting back into patient".
Event or Problem Description
Healthcare professional reported a left side "implant ruptured when putting back into patient".Device has been explanted.
Event or Problem Description
Healthcare professional reported a left side "implant ruptured when putting back into patient".Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture-ndr: not applicable as the event is not related to the device.Use error: observed three openings on anterior assessed as surgical damage.Additional observations: red particles and non-penetrating nick observed on the device.No further actions are required as the device was implanted.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17330072
• Report Number: 9617229-2023-11611
• Device Sequence Number: 6319352
• Product Code: FTR
• UDI-Device Identifier: 10888628030190
• UDI-Public: 10888628030190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 11/04/2025
• Device Model Number: SCF-695
• Device Catalogue Number: SCF-695
• Device Lot Number: 3480519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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