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Device Problem
Unintended Movement (3026)
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Patient Problem
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 unk - screws: locking: trauma/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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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It was reported that on (b)(6) 2020, a hardware removal was performed due to a nonunion.The original case was done (2) two years ago and the patient did not follow up.However, the patient began lifted cement bags and the plate loosed and the fixation failed.Thus, a wrist fusion plate was removed from the patient and bone grafted was done and a new wrist fusion plate was used to fixate.The procedure outcome was unknown.There was no patient consequence.This is report 07 of 07 of (b)(4).
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Search Alerts/Recalls
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