K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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Model Number 801-37545M |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2020 |
Event Type
malfunction
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Event Description
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It was reported that after final locking, the rod was still able to slide in the head of the mesa deformity uniplanar screw.Surgery was successfully completed with another screw, and an unknown delay.No adverse consequences, or medical intervention were reported.
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Manufacturer Narrative
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Visual inspection: the returned screw had loss of anodization and slight deformation around the inner and outer collet which did not impact the functionality of the device.Functional inspection: the complaint screw was functionally inspected using the returned denali rod as well as a sample rod.The device was able to final lock onto the rods, using a sample quick locker, without issue.The rods were not able to slide along the collets, as reported.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It is possible that the screw was not in a completely locked state during the procedure, causing the rod to slip along the screw head.As certain maneuvers applied during the procedure could not be replicated during functional testing, the failure mode could not be confirmed and the root cause could not be determined conclusively.
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Event Description
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It was reported that after final locking, the rod was still able to slide in the head of the mesa deformity uniplanar screw.Surgery was successfully completed with another screw and an unknown delay.No adverse consequences or medical intervention were reported.
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Search Alerts/Recalls
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