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

Model Number	SRX-200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Visual analysis: visual analysis of the identified photos: opening on anterior and red particles in the shell.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.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: one of these implants ruptured as doctor was going to place it in patient.
Event or Problem Description
Healthcare professional informed that one of the implant was ruptured, the doctor was going to place it in the patient.Device was not implanted.
Event or Problem Description
Healthcare professional informed that one of the implant was ruptured, the doctor was going to place it in the patient.Device was not implanted.

• 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; CS
• MDR Report Key: 10520234
• Report Number: 9617229-2020-14807
• Device Sequence Number: 14312228
• Product Code: FTR
• UDI-Device Identifier: 10888628007437
• UDI-Public: 10888628007437
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• Device Model Number: SRX-200
• Device Catalogue Number: SRX-200
• Device Lot Number: 3397352
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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