Catalog Number 201.932 |
Device Problems
Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: in four (4) patients the imf screws broke in half, all in the same location during insertion after three (3) or four (4) turns.Patient #1: two screws broke 8mm and 12mm long.The 8mm screw broke below bone level.Surgeon tried to remove the shaft and was un-successful.Surgeon spent 30 minutes trying to remove the shaft not wanting to damage the tooth root.The shaft of the screw remains in the patients bone.There was significantly prolonged anesthesia.It was noted by the surgeon: another case (patient) he was able to remove a broken 12mm screw.It is not known which of the four patients this report belongs to.This report is on patient #1 with two broken screws.This is 1 of 2 reports for complaint (b)(4).
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Manufacturer Narrative
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This device used for treatment and not diagnosis.The device was returned and the investigation is ongoing.Placeholder.
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Manufacturer Narrative
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Manufacturing evaluation was conducted and it states that the tip was broken off.The part was received inside a sterilization bag (the original packaging/labeling was not provided.The screws were not etched (lot numbers unknown).The parts returned were two body screws (from the side of the screw head) and screw tip.The threaded parts showed post production damages.The conclusion of the product investigation is that the complained parts are conforming from a manufacturing perspective.The returned parts were re-inspected and all relevant product features meet specification.No manufacturing related anomaly could be detected.
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Search Alerts/Recalls
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