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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Paralysis (1997)
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Event Date 03/17/2021 |
Event Type
Injury
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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.Report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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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This report is being filed after the review of the following journal article: toll, b.J.Et al (2021), crossing the cervicothoracic junction in complex pediatric deformity using anterior cervical discectomy and fusion: a case series, child's nervous system, vol.37 (xx), pages 1957¿1964 (usa).The aim of this single-center retrospective cohort study is to evaluate the utility of anterior cervical discectomy and fusion (acdf) in addition to traditional psf crossing the cervicothoracic junction in order to mitigate implant-related complications.Between january 2008 and december 2016, a total of 10 patients (4 boys and 6 girls) with a mean age of 12.8 ± 3.26 years (range 6¿19) were included in the study.All patients were treated surgically with posterior spinal fusion (psf) across the cervicothoracic junction with anterior cervical discectomy and fusion (acdf).Among these patients, 1 case (patient no.9: 12-year-old girl) had a vertical expandable prosthetic titanium rib (veptr) prior to fusion.The average follow-up was 3.4 ± 0.9 years (range 2¿5).The following complications were reported as follows: patient 9: a 12-year-old girl experienced paraplegia due to her severe deformity and underwent posterior spinal fusion (psf) across the cervicothoracic junction with anterior cervical discectomy and fusion (acdf).Following definitive intervention, her neurological symptoms resolved.This report is for an unk - construct: veptr.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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