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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 11/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Additional product code: emm, fzo.This report is for an unknown cutting instruments: chisel/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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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It was reported that on (b)(6) 2018, during an unknown procedure, a primary chisel was used to cut the keel prior to inserting the implant and the vertebral body cracked slightly.The surgeon noted the fracture would not worsen or cause instability so he implanted the prodisc-c.It was further reported that in no way is this associated with the prodisc-c as it occurred after the appropriate trial was selected and the keel was being cut with the chisel.There was no surgical delay.Procedure outcome and patient status is unknown.This complaint involves one (1) device.This report is 1 of 1 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.Complainant part is not expected to be returned for manufacturer review/investigation.There are no additional procodes for this unknown chisel.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 for an unknown chisel.
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Search Alerts/Recalls
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