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Device Problem
Unintended Movement (3026)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Additional narrative: (b)(6).Date of device migration is not known.510k: this report is for an unknown 5.0mm proximal locking screw/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.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 patient was implanted with an unknown tibial nail and screws on (b)(6) 2016.During a follow up visit on (b)(6) 2017 it was noted that the 5.0mm proximal locking screw was backing out of the tibial nail and slightly protruding.It is unknown if the patient experienced any pain or other symptoms.Surgeon performed a revision surgery on (b)(6) 2017 where the proximal locking screw was removed.Patient was not revised to a new screw.The procedure was successfully completed without any delay and the patient is reported to be in stable condition.Concomitant devices reported: tibial nail (part number unknown, lot number unknown, quantity 1).
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Manufacturer Narrative
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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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