MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS: VIPER 2; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number UNK - MONO/POLYAXIAL SCREWS: V |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/16/2019 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in egypt as follows: this report is being filed after the review of the following journal article: elenany s.A., alkosha h.A., and ibrahiem m.S.(2019), role of minimally invasive percutaneous fixation in thoracolumbar fractures: a prospective study, egyptian journal of neurosurgery, vol.34 (40), pages 1-14 (egypt).The aim of this study is to explore the technique and to evaluate feasibility, safety, and outcome of percutaneous transpedicular fixation in the management of thoracolumbar fractures.Between may 2016 and june 2017, a total of 20 patients (60% male and 40% female; mean age of 33.85 years [range 20¿49 years]) who underwent percutaneous transpedicular fixations were included in the study.A depuy spine viper 2 system was used with these tools: guidewire, tap cannula, self-drilling cannulated tap, dilators, cannulated polyaxial viper screws with extensions, rods, measurements, and rod holder.The patients were followed up for 12 months.The following complications were reported as follows: 6 cases had only one laterally malpositioned screw each.5 patients were suffering from moderate pain (f4).7 cases had no fusion after 6 months.3 cases had no fusion after 12 months.This report is for an unknown depuy spine viper 2 system.This is report 1 of 1 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.
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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.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown viper 2 pedicle screws and rods/unknown lot.Part and lot number 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.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Search Alerts/Recalls
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