|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P100003 / PAS002 |
Date Original Protocol Accepted |
09/28/2012
|
Date Current Protocol Accepted |
05/08/2014
|
Study Name |
Enhanced Surveillance
|
Device Name |
SECURE-C ARTIFICIAL CERVICAL DISC
|
General Study Protocol Parameters |
Study Design |
Enhanced Surveillance
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Detailed Study Protocol Parameters |
Study Objectives |
Objectives-To assess safety profile of the secure-C disc under general condition of use. Design- ESS
|
Study Population |
All patients who have received secure-C
|
Sample Size |
N/A
|
Key Study Endpoints |
Anticipated and un-anticipated adverse events including, but not limited to major vessel injury, neurological damage, or nerve injury, device migration, removal, revision, and heterotopic codification.
|
Follow-up Visits and Length of Follow-up |
10 years Assessments: Annual for surgeon surveys, ongoing for the complains, explants and MDRs
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
Not applicable
|
Actual Number of Sites Enrolled |
Not applicable
|
Patient Follow-up Rate |
Not applicable
|
Final Safety Findings |
A cumulative total of 7318 implants have been sold in the U.S. since the PMA approval date of September 28, 2012, to September 13, 2022. A cumulative total of 78 MDRs have been reported for the SECURE-C system sold in the U.S. since the approval date to September 13, 2022. 74 of the US MDRs were device related while 4 were instrument related. A cumulative total of 594 implants have been sold outside of the U.S. since the PMA approval date of September 28, 2012, to September 13, 2022. A cumulative total of 1 MDRs have been reported outside of the U.S since the approval date to September 13, 2022, and it was instrument related.
|
Final Effect Findings |
Not applicable
|
Study Strengths & Weaknesses |
The study permitted monitoring of the AEs occurrence in the broader population of the device users. Due to the study design, it is impossible to meaningfully evaluate the AEs rates. Further, due to study design and lack of clinical information reported to the company it is difficult to find any particular trends in occurrence of heterotopic ossification and osteolysis.
|
Recommendations for Labeling Changes |
Yes
|