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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 Type
Injury
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Manufacturer Narrative
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This report is for an unknown lcp plate/unknown lot.Part and lot number 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 (b)(6) reports an event as follows: it was reported that a patient was implanted with an locking compression plate (lcp) on an unknown date.The hardware was removed on (b)(6) 2018 due to a foreign body.During the procedure, the tip of the stardrive screwdriver shaft was stripped, causing difficulty in removing a screw from the plate.The surgery was delayed by forty (40) minutes.There was no adverse consequence to the patient.Concomitant devices: screws (part: unknown, lot: unknown, quantity: 1).This report is for an unknown lcp plate.This is report 1 of 1 for (b)(4) and captures the removal of the lcp plate.The intraoperative event of the stripped screwdriver shaft is captured in (b)(4).
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Search Alerts/Recalls
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