MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Spinal Cord Injury (2432)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that this was a posterior cervical fusion (c2-th3) performed on (b)(6) 2018.The details of the products used in the initial surgery are unknown.After the surgery, during follow-up, neurological symptoms were observed.The extension surgery was performed on (b)(6) 2024, due to c1 cervical spondylosis.The discectomy was performed and an occipital plate, rods, and connectors were added, and an extension procedure was performed to connect the rods to the rods from a previous fusion.No further information is available.This pc is related to (b)(4) which reports the event occurred in the extension surgery performed on (b)(6) 2024.This pc reports the initial surgery and the extension surgery due to c1 cervical spondylosis.This report is for unknown rods 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.This report is for an unknown rods/unknown lot.Part and lot numbers are unknown; udi number is unknown.E1: initial reporter is j&j company representative 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.E1: initial reporter's number added.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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