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

Model Number	TRF-385
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2019
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: rupture and product anxiety.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side rupture and additionally reported 'product anxiety' due to textured device.Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported "any creases associated with hole".Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5., d.7., d.10., g.3., h.3., h.6.
Additional Manufacturer Narrative
Device evaluation: visual and microscopic analysis of the returned device identified: an extended sharp opening (a dimension measurement in the shell was performed which identify the thickness within specification) and a weight test of the explanted material was verified and it was underweight.Based on the device analysis the final assessment is: a sharp opening assessed as unidentified(tear) opening.
Event or Problem Description
Healthcare professional reported a left side rupture and additionally reported 'product anxiety' due to textured device and "any creases associated with hole".Device has been explanted.

• Brand Name: INSPIRA TEXTURED 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: 9317692
• Report Number: 9617229-2019-18124
• Device Sequence Number: 607411
• Product Code: FTR
• UDI-Device Identifier: 10888628008328
• UDI-Public: 10888628008328
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2021
• Device Model Number: TRF-385
• Device Catalogue Number: TRF-385
• Device Lot Number: 2875215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 01/30/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/28/2020; 02/26/2020
• 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
• Patient Age: 38 YR