MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA MODPROF 360CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	SSZ-M360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
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: broken device.
Event or Problem Description
Healthcare professional reported "rupture on the edge" found during implant surgery.The device was not implanted.
Event or Problem Description
Hcp reported via allergan sales rep that during implantation surgery kettle funnel was used to place the sizer in and noticed ¿a rupture on the edge where it starts to round up to profile the implant." device was not implanted.Surgery was completed with a backup device.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: broken device: observed an opening in the posterior side assessed as to surgical damage.Additional observations: red particles in the surface of the shell.No further actions are required as the device was implanted.

• Brand Name: NATRELLE INSPIRA MODPROF 360CC SSZ 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: 15722547
• Report Number: 9617229-2022-19362
• Device Sequence Number: 2920355
• Product Code: MRD
• UDI-Device Identifier: 10888628045668
• UDI-Public: 10888628045668
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SSZ-M360
• Device Catalogue Number: SSZ-M360
• Device Lot Number: 3583143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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: Other
• Patient Sex: Female