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-615
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
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.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
Device analysis lab received a "ruptured" device.Device has been explanted.
Event or Problem Description
Device analysis lab received a "ruptured" device.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: continued d.6b explant date: device explanted, no date provided.Based on the device analysis grid, the assessments of the complaint are: ¿ rupture: observed opening on anterior side assessed surgical damage.Additional observations: ¿ observed creases on the device.No further actions are required as the device was implanted.
Event or Problem Description
Device analysis lab reported left side "ruptured." healthcare professional reported "left implant was ruptured was coming out of incision site." device has been explanted.
Additional Manufacturer Narrative
Information contained in this report was previously submitted via emdr manufacturer report number 9617229-2023-03916.All information has been consolidated into this report.The event of erosion is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• 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: 17374935
• Report Number: 9617229-2023-12978
• Device Sequence Number: 7036370
• Product Code: FTR
• UDI-Device Identifier: 10888628030381
• UDI-Public: 10888628030381
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/14/2023

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: 01/06/2025
• Device Model Number: SCX-615
• Device Catalogue Number: SCX-615
• Device Lot Number: 3412058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 10/23/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/16/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 59 KG