MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 179704880 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that on an unknown date, the surgeon performed a spine surgery (t10-s2), and it went as planned.At some point well after the case, two sai screws broke.The patient is aware and has discussed with the surgeon, and there is no planned revision surgery at this time.This report involves one viper system polyaxial wide lag screw 5.5 8 x 80mm.This is report 1 of 2 for (b)(4).
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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.H10 additional narrative: 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.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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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.H10 additional narrative: d2: additional procodes: kwp, kwq, mnh, mni, osh.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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