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

Model Number	TCM-330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/14/2021
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.
Event or Problem Description
Healthcare professional reported a right side rupture.Device has been explanted.
Event or Problem Description
Healthcare professional reported a right side rupture.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: broken shell and others, underweight, and missing a piece of shell (25-50%).A microscopic analysis was performed which identified: a striated broken on anterior and a sharp broken on posterior.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp broken on posterior assessed as unidentified (tear) opening.Missing shell assessed as inconclusive.A striated broken on anterior assessed as surgical damage.

• Brand Name: INSPIRA TEXTURE COHESIVE 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
• MDR Report Key: 12385419
• Report Number: 9617229-2021-49459
• Device Sequence Number: 14675696
• Product Code: FTR
• UDI-Device Identifier: 10888628030886
• UDI-Public: 10888628030886
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 11/16/2021
• Device Model Number: TCM-330
• Device Catalogue Number: TCM-330
• Device Lot Number: 3000725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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: 36 YR
• Patient Weight: 50