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Device Problem
Crack (1135)
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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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If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for one (1) unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown plate.Pma/510(k) number is not available.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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.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 an unknown date, patient was initially implanted with two plates onto her tibia and fibula due to a ski accident that fractured the patient¿s bones.Several months later, doctors found that the tibia locking plate had cracked.On an unknown date, patient underwent a revision surgery and the plate was replaced.Patient and procedure outcome are unknown.Concomitant device: fibula locking plate (part unknown, lot unknown, quantity 1), screws (part unknown, lot unknown, quantity unknown).This report is for one (1) unknown tibial plate.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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