MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 450CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	MSZ-F450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture" against right device.The device has been explanted and replaced.
Additional Manufacturer Narrative
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: rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6 device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture: not observed on the device.Additional observations: ¿ crease flat is observed.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional reported "rupture" against right device.The device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported "rupture" against right device.The device has been explanted and replaced.
Additional Manufacturer Narrative
Information in this report was previous submitted in mdr 2641652, which was found to be a duplicate of this pr 2639244.All information is being consolidated into this record.Additional, changed, and/or corrected data: a2, a4, d4, h4.

• Brand Name: NATRELLE INSPIRA FULLPROF 450CC 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15544255
• Report Number: 9617229-2022-16820
• Device Sequence Number: 5329245
• Product Code: MRD
• UDI-Device Identifier: 10888628009349
• UDI-Public: 10888628009349
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022
• 2 Devices were Involved in the Event: 1 2

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: 05/10/2026
• Device Model Number: MSZ-F450
• Device Catalogue Number: MSZ-F450
• Device Lot Number: 3525529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/25/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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: 73 KG