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

Model Number	TRM-275
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/18/2020
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: right-side rupture and a bilateral exchange from textured to smooth breast implants due to the patient¿s concern with the product.
Event or Problem Description
Patient reported "right-side rupture and exchange from textured to smooth breast implants due to the patient¿s concern with the product".Device has been explanted.
Event or Problem Description
Healthcare professional reported the event.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified broken shell and others, missing a piece of shell (0-25%), and crease fold.Weight measurement identified device was underweight.A microscopic analysis was performed which identified one broken sharp on the posterior and wear abrasion.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis, the final assessment is one sharp broken on the posterior assessed as unidentified (tear) opening and missing shell due to inconclusive.

• 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: 11023585
• Report Number: 9617229-2020-20680
• Device Sequence Number: 11886335
• Product Code: FTR
• UDI-Device Identifier: 10888628008069
• UDI-Public: 10888628008069
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/15/2021

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: 12/29/2020
• Device Model Number: TRM-275
• Device Catalogue Number: TRM-275
• Device Lot Number: 2862227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/15/2021
• 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: 27 YR