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

Model Number	TRX-495
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Fistula (1862); Failure of Implant (1924)
Date of Event	09/16/2020
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: rupture and concern with product.
Event or Problem Description
Healthcare professional reported left side rupture and "exchange due to concern with the product." device remains implanted.
Event or Problem Description
Healthcare professional additionally reported "fissure and fistula of nipple" and "left breast lump for weeks." device has been explanted.
Additional Manufacturer Narrative
The event of "fistula" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare professional reported left side rupture and exchange due to concern with the product.Healthcare professional additionally reported "fissure and fistula of nipple" and "left breast lump for weeks." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified crease flat.Weight measurement identified device weight to the specification.Cloudy was observed after autoclave disinfection process.Based on the device analysis, the final assessment is no issues found related with the manufacturing process.Continued h.6.Health effect - impact code: f2203.

• 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: 10820296
• Report Number: 9617229-2020-18295
• Device Sequence Number: 16425789
• Product Code: FTR
• UDI-Device Identifier: 10888628008540
• UDI-Public: 10888628008540
• Combination Product (Y/N): N
• Initial Reporter State: NM
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2021

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: 01/17/2021
• Device Model Number: TRX-495
• Device Catalogue Number: TRX-495
• Device Lot Number: 2872208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/13/2020; 12/15/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/11/2020; 01/07/2021
• 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: 41 YR