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

Model Number	SRX-310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
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.The reason for reoperation is: device ruptured up on insertion with funnel.Device evaluation: based on the device analysis grid, the assessments of the complaint are: insufficient information: no observations are performed for the complaint as the event is insufficient information.Additional observations: red particles observed.Crease fold observed.Observed crease sharp broken on radius side assessed as fold flaw opening.And missing piece of shell assessed as inconclusive.Stress marks observed.
Event or Problem Description
Healthcare professional reported unknown side device ruptured up on insertion with funnel.It is unknown if a back-up device was used.Device was not implanted.
Additional Manufacturer Narrative
Device evaluation results: the device related to the reported event of broken device was received on nov 16, 2022, with lot number 3563157.Based on the device analysis grid, the assessments of the complaint are: broken device: observed crease sharp broken on radius side assessed as fold flaw opening.And missing piece of shell assessed as inconclusive.Additional observations: red particles observed.Crease fold observed.Stress marks observed.No further actions are required.Additional, corrected and/or changed data: device analysis correction.
Event or Problem Description
Healthcare professional reported unknown side device ruptured up on insertion with funnel.It is unknown if a back-up device was used.Device was not implanted.

• Brand Name: INSPIRA SMOOTH 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: 16023754
• Report Number: 9617229-2022-23582
• Device Sequence Number: 15193609
• Product Code: FTR
• UDI-Device Identifier: 10888628007475
• UDI-Public: 10888628007475
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• 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
• Report Date (Section B): 03/09/2023

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 Expiration Date: 09/23/2026
• Device Model Number: SRX-310
• Device Catalogue Number: SRX-310
• Device Lot Number: 3563157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2021
• 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: Unknown