• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

OSB Lead-Enhanced Surveillance


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P060023 / PAS002
Current Plan Approved 05/12/2009
Study Name OSB Lead-Enhanced Surveillance
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Sponsor collects the information for any adverse events and complaints, including those which are not associated with any adverse clinical effect, received by the company for the BRYAN device following PMA approval.
Study Population Description Study population is as per device indication.This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy.
Sample Size NA
Data Collection The primary outcome variable, overall success, is defined below. A patient will be considered an overall success if all of the following conditions are met:

- Postoperative Neck Disability Index score improvement of at least 15-points from preoperative (score decrease signifies improvement);

- Maintenance or improvement in neurological status from preoperative;

- No serious adverse event classified as implant associated or implant/surgical procedure associated; and

- No additional surgical procedure classified as a "failure". Second surgery "failures" are additional surgeries that occur after the treatment surgery that affect the original device configuration.
Follow-up Visits and Length of Follow-up This reporting occurs at six-month intervals for the first two years of approval and then continues on an annual basis until five years after PMA approval.
Final Study Results
Interim Safety Information This ESS report covers the period from October 16, 2009 to April 12, 2010. No complaints and adverse events were reported for the BRYAN Cervical Disc or the instruments used with the implants in the US during the covered period. A total of 4 devices have been sold during this time period. There were 7 outside of the US complaints and adverse events recorded for the BRYAN Cervical Disc implants during the time period from October 16, 2009 to April 12, 2010. Two events were related to a revision surgery due to postoperative pain. one evet was related to a revision surgery following osteolysis and a low grade infection. One event was related to a revision surgery following formation of posterior osteophytes. Two events related to the device, which were reported that the Bryan Disc made a cracking noise when a surgeon moved the implants between his thumb and index finger. These two devices were not used to treat the 2 patients and no complications were reported. The last patient had been reported by the surgeon that there were bubbles coming from the Bryan Disc before implanting into the patient due to the torn sheath. Another implant was used to treat patient and no complications were reported.
Number of Patients N/A - enhanced surveillance stud




















































































































Number of Sites N/A - enhanced surveillance study
Follow-up Rate Not applicable enhanced surveillance study

The study duration was 5 years.

Safety Findings A cumulative total of 1950* implants have been sold in the U.S. since the PMA approval date of May 12,

2009 to March 11, 2014. A cumulative total of twenty five MDRs have been reported for implants sold in the U.S. since the approval date to March 11, 2014. A cumulative total of twenty MDRs have been reported for instruments sold in the U.S. since the approval date. A cumulative total of 7769 implants have been sold outside of the U.S. since the PMA approval date of May 12, 2009 to March 11, 2014. A cumulative total of 86 MDRs have been reported for implants sold outside of the U.S. since the approval date to March 11, 2014.

Effect Findings N/A
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.

Label Changes Yes

Bryan Cervical Disc implantation associated with higher level of surrounding tissue dissection than other artificial disc systems currently on the market. This in turn leads to higher incidents of HO. The HO incidents were observed in the ESS study.



OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/10/2009 11/17/2009 Overdue/Received
1 year report 05/12/2010 05/12/2010 On Time
18 month report 11/10/2010 11/17/2010 Overdue/Received
2 year report 06/12/2011 08/25/2011 Overdue/Received
3 year report 05/11/2012 04/27/2012 On Time
4 year report 05/11/2013 04/23/2013 On Time
5 year report 05/11/2014 04/17/2014 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-