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

Model Number	SSM-755
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/16/2021
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.The event of capsular contract baker grade iii/iv is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: capsular contract baker grade iii/iv.
Event or Problem Description
Healthcare professional reported right side baker grade iii/iv capsular contracture.Device has been explanted.
Event or Problem Description
Healthcare professional reported right side baker grade iii/iv capsular contracture.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: analysis visual of the return device identified a crease fold and weight was to the spec.Cloudy in the gel observed after autoclave cycle.Observed split in patch area ¿ss¿, it is out of specification per (b)(4) was identified which is characterized as a workmanship.Base on the device analysis the final assessment is: observed split in patch area, was identified which is characterized as a workmanship.
Additional Manufacturer Narrative
Further investigation: "the review of the documentation associated to the manufacturing process, indicates that all devices were released in accordance with allergan procedures.And no anomalies were found in the documents or in the personnel training related to the reported event.According to the device analysis performed in the laboratory.A split in patch area (ss) was found, which is considered as workmanship.This finding is not related with the reported event.A review of the current risk documents was performed.And the event of split in patch area is a known event, for which manufacturing 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 split in patch area will continue to be monitored and corrective actions will be taken in the future if deemed appropriate".
Event or Problem Description
Healthcare professional reported, right side baker grade iii/iv, capsular contracture.Device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12787542
• Report Number: 9617229-2021-56043
• Device Sequence Number: 1427540
• Product Code: FTR
• UDI-Device Identifier: 10888628033047
• UDI-Public: 10888628033047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2022

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: 10/09/2025
• Device Model Number: SSM-755
• Device Catalogue Number: SSM-755
• Device Lot Number: 3473915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 12/28/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/10/2021; 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 58 KG