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

Model Number	SRLP-540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
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: ruptured before device was implanted.
Event or Problem Description
Healthcare professional reported "ruptured." device was not implanted.Surgery was completed with a back-up device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.2.
Event or Problem Description
Healthcare professional reported "ruptured." device was not implanted.Surgery was completed with a back-up device.

• 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: 10284140
• Report Number: 9617229-2020-11419
• Device Sequence Number: 2780172
• Product Code: FTR
• UDI-Device Identifier: 10888628006973
• UDI-Public: 10888628006973
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: SRLP-540
• Device Catalogue Number: SRLP-540
• Device Lot Number: 3291620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 04/03/2021
• 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: Other; Required Intervention
• Patient Age: 37 YR