OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM; DRILL, BONE, POWERED
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Catalog Number 03.503.408 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.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 synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, during the inter-molar distraction osteogenesis (imdo) procedure, two (2) trumatch mandible guide were heating up during pre-drilling.The cylinder and guides were heating up due to the drill.It was noted three (3) drill bits were touching the cylinder because of the angulation of the guide.There was no surgical delay.There was no adverse consequence to the patient and there was no issue with the plates or screws.Concomitant devices reported: mandible plate (part/lot unknown, quantity unknown), mandible screw (part/lot unknown, quantity unknown).This report is for a drill bit.This is report 1 of 3 for (b)(4).
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Search Alerts/Recalls
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