K2M, INC. EXPANDABLE DRILL GUIDE; SIZE 15 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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Model Number 2008-90060 |
Device Problems
Material Integrity Problem (2978); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.The surgeon intends to do a follow up posterior fixation on another day.This report will capture the expandable grill guide.
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Manufacturer Narrative
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Return status of the device is unknown.
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Event Description
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It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.The surgeon intends to do a follow up posterior fixation on another day.This report will capture the expandable grill guide.
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Manufacturer Narrative
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Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were observed.Due to lack of information, an exact cause of the reported event cannot be determined.Potential causes include: labelling wearing off due to age of device/ extensive use of device, etc.
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Search Alerts/Recalls
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