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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown rods/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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 (b)(6) as follows: it was reported that on an unknown date, that a (b)(6) year-old female patient underwent the initial procedure with moss miami expedium, ten (10) years later, the sai revision was performed to extend the fusion range up to the ilium.This information was presented at the 2020 annual meeting of the (b)(6) for adult spinal deformity.No further information was available.Concomitant devices reported: screws (part number unknown, lot unknown, quantity unknown).This report involves unknown rods.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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