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Model Number OSSEOCISION 120V |
Device Problems
Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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Nakanishi did not receive information about the patient's age and weight.
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Event Description
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On march 22, 2017, nakanishi received an e-mail from a distributor ((b)(4)) about a problem with an nsk oral surgical unit.Details are as follows.- the event occurred on (b)(6) 2017.- a dentist was performing an oral surgery on a patient using osseocision ttf120.- suddenly, the error code 3 appeared on the monitor, and the drill unit did not work.- the dentist discontinued the procedure and sent the patient home.- the patient will be returned to the dental office when the unit is repaired.
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Manufacturer Narrative
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On august 8, 2017, nakanishi attempted to obtain information about the patient's age and weight from the distributor, however the information was not provided.Due to the device not being returned from the distributor, nakanishi inc., (b)(4) (manufacturer) made the dhr examination as the investigation approach.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.
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Search Alerts/Recalls
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