Catalog Number UNK - SCREWS: ZERO-P |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/12/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D1, d2, d3, d4, g4-510k: this report is for an unk - screws: zero-p are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: department of neurosurgery, chung ang university college of medicine, h3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes reports an event in korea, south as follows: this report is being filed after the review of the following journal article: lee, y.S., kim, y.B., & park, s.W.(2015) does a zero-profile anchored cage offer additional stabilization as anterior cervical plate?, spine journal volume 40 (10), pages e563 - e570 (south korea).This retrospective cohort study aimed to compare 3 different surgical methods of single-level anterior cervical interbody fusion consisting of stand-alone cages (scs), cages with plates (cps), and anchored cages (acs) (zero-profile) focusing on postoperative retention and motion stabilization.This study included a total of 101 patients which was divided into 3 groups: stand-alone cages (sc), cages with plates (cp), and anchor cages (ac).Between 2005 and 2011, there were 60 patients in sc group (30 male and 30 female) with a mean age of 53.62 years, and 23 patients (11 male and 12 female) with a mean age of 57.26 years in cp group.While between january 2012 to june 2013 there were 18 patients (11 male and 7 female) with a mean age of 52.89 years were included.These patients had a single-level cervical degenerative disease of the subaxial cervical spine (c3-c7) who underwent surgery for neck pain and radiculopathy without improvement after more than 6 months of conservative therapy.A cervios (synthes, west chester, pa) was used in some patients in groups sc & cp, while a zero-p (synthes, zuchwil, switzerland) was used in group ac.The mean follow-up period for all patients was 19.9 months.For all patients, a cage filled with dbx putty (musculoskeletal transplant foundation, available through synthes, paoli, pa) was used as bone graft substitute.The following complications were reported as follows: stand-alone cages (scs) - unknown number of patients developed subsidence - unknown number of patients with nonfusion the distance of interspinous process - unknown number of patients with nonfusion as per bridwell fusion classification cages with plates (cps) - unknown number of patients developed subsidence - unknown number of patients with nonfusion on distance of interspinous process - unknown number of patients with nonfusion as per bridwell fusion classification anchored cages (acs) 5 patients = developed subsidence 1 patient = with nonfusion on distance of interspinous process 4 patients = who developed subsidence had screw loosening this report is for an unknown cervious synthes, and "unknown" zero-p synthes.This is report 3 of 4 for complaint (b)(4).6.Tests/lab data including dates.
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Search Alerts/Recalls
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