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

Catalog Number	TRM-310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification to b.3.Date of occurrence: (b)(6) 2023.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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: patient's concern with the product, rupture.
Event or Problem Description
Patient reported left side implant removal due to the concerns of the product.Later, healthcare professional reported a left side exchange due to concerns with the product and rupture.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation reported event of rupture and anxiety-product/procedure was received on (b)(6) 2023, with lot number 2857581.The device is a silicone device.Based on the device analysis grid, the assessments of the complaint are: ¿ rupture: observed a broken-on posterior assessed as an unidentified (tear) opening (shell thickness within spec).¿ anxiety-product/procedure: unable to observe since it is not related to the device.Additional observations: ¿ no other observations observed.
Event or Problem Description
Patient reported left side implant removal due to the concerns of the product.Later, healthcare professional reported a left side exchange due to concerns with the product and rupture.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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17738024
• Report Number: 9617229-2023-15953
• Device Sequence Number: 12481862
• Product Code: FTR
• UDI-Device Identifier: 10888628008083
• UDI-Public: 10888628008083
• Combination Product (Y/N): N
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 12/24/2020
• Device Catalogue Number: TRM-310
• Device Lot Number: 2857581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 66 KG