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

Model Number	SRL-350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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: rupture.
Event or Problem Description
Healthcare professional reported left side rupture.Device remains implanted.
Event or Problem Description
Healthcare professional reported left side rupture, pain and 2 small simple cysts.Device was explanted.
Additional Manufacturer Narrative
Device evaluation: a visual analysis of the returned device identified the weight of the device was within specification, voids, and a crease fold.After the autoclave cycle a cloudy color in the gel was observed.Based on the device analysis the final assessment is: no openings were observed on the device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, b.6, d.6b, g.2, h.6.
Event or Problem Description
Additionally, healthcare professional reported pain and 2 small simple cysts.Device was explanted.

• 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: 10885467
• Report Number: 9617229-2020-19049
• Device Sequence Number: 11462916
• Product Code: FTR
• UDI-Device Identifier: 10888628006737
• UDI-Public: 10888628006737
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2021

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: 01/16/2021
• Device Model Number: SRL-350
• Device Catalogue Number: SRL-350
• Device Lot Number: 2872051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 01/25/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/07/2021; 02/23/2021
• 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: Required Intervention
• Patient Age: 43 YR