STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 6000-999-002 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2019 |
Event Type
malfunction
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Event Description
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It was reported that, during testing, it was observed that the locking mechanism is missing; this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
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Manufacturer Narrative
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Additional information added for d4, d10, h3, h4 device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported that, during testing, it was observed that the locking mechanism is missing; this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
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Search Alerts/Recalls
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