MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 615CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	SSZ-X615
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.The reason for reoperation is: "that the inner thermoform and outer thermoform trays were stuck together on all the sizers that were used for the case.We were still able to use the sizers, but poses a great concern to sterility".
Event or Problem Description
Healthcare professional reported "that the inner thermoform and outer thermoform trays were stuck together on all the sizers that were used for the case.We were still able to use the sizers, but poses a great concern to sterility." device has not been implanted.
Event or Problem Description
Healthcare professional reported, "that the inner thermoform and outer thermoform trays were stuck together on all the sizers, that were used for the case.We were still able to use the sizers, but poses a great concern to sterility".Device has not been implanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ tyvek or thermoform sticking: observed delamination of the lid.¿ use error: not observed, device is inside sealed thermoform.No additional observations are performed.A further investigation is requested for the event of lid delamination.
Event or Problem Description
Healthcare professional reported "that the inner thermoform and outer thermoform trays were stuck together on all the sizers that were used for the case.We were still able to use the sizers, but poses a great concern to sterility." device has not been implanted.
Event or Problem Description
Healthcare professional reported "that the inner thermoform and outer thermoform trays were stuck together on all the sizers that were used for the case.We were still able to use the sizers, but poses a great concern to sterility." device has not been implanted.
Additional Manufacturer Narrative
Further investigation: the review of the documentation associated to the manufacturing process indicates that all devices with lot number 3609983 were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.Additionally, (b)(4) was opened to perform an exploratory study to evaluate the impact of dry heat sterilization cycles on packaging seal strength.According to the device analysis performed in the laboratory, was observed delamination in the lid, and this further investigation was requested to review the event.A review of the current risk documents pfmea-bi pkg and lblg rev.11.0 was performed, and the event of lid delamination is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with lid delamination will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.

• Brand Name: NATRELLE INSPIRA X-FULL 615CC 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: 16221494
• Report Number: 9617229-2023-01053
• Device Sequence Number: 7492144
• Product Code: MRD
• UDI-Device Identifier: 10888628045934
• UDI-Public: 10888628045934
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SSZ-X615
• Device Catalogue Number: SSZ-X615
• Device Lot Number: 3609983
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 01/23/2023; 09/07/2023; 10/06/2023
• Initial Report FDA Received Date: 01/21/2023
• Supplement Report FDA Received Date: 02/10/2023; 10/02/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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: Required Intervention; Other
• Patient Sex: Female