MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 545CC SIZER (US); SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-X545
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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 "rupture" against unknown side device (sizer).The device was never implanted.
Event or Problem Description
Healthcare professional reported, "rupture".Against unknown side device (sizer).The device was never implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, opening, underweight.A microscopic analysis was performed which identify, a striated edge opening.Based on the device analysis, the final assessment is: two striated edge openings on radius side assessed, as surgical damage.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h6.
Event or Problem Description
Healthcare professional reported "rupture" against unknown side device (sizer).The device was never implanted.

• Brand Name: NATRELLE INSPIRA X-FULL 545CC SIZER (US)
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12721874
• Report Number: 9617229-2021-54941
• Device Sequence Number: 17213916
• Product Code: MRD
• UDI-Device Identifier: 10888628009561
• UDI-Public: 10888628009561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021

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: 07/04/2025
• Device Catalogue Number: MSZ-X545
• Device Lot Number: 3453474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 04/05/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/16/2021; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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