K2M, INC. SACROILIAC SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø10.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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Model Number E5111-01040 |
Device Problems
Fracture (1260); Difficult to Insert (1316); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device remains implanted in patient.
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Event Description
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It was reported that when an everest xt fenestrated extended tab sacroiliac screw got stuck 2/3 of the way in s1, the screw tabs fractured intra-operatively.Surgery was successfully completed with a 30 to 40 minute delay.No adverse consequences or medical intervention were reported.
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Manufacturer Narrative
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Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no relevant manufacturing issues or similar complaints were identified.Additional communication provided that an audible ¿crunching¿ of the bone was heard during screw insertion.The screw stopped advancing about 2/3rds of the way into the bone.The screw was left inserted, sticking out from the patient¿s bone.The audible sound during initial insertion may indicate the patient had sclerotic bone, or bone cement residue from the previous implant.This would require higher forces needed to insert the screw into the pedicle.The most likely root cause of the screw's inability to be fully inserted into the pedicle is due to the patient's bone quality and previous implantations, however this cannot be conclusively determined.
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Event Description
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It was reported that when an everest xt fenestrated extended tab sacroiliac screw got stuck 2/3 of the way in s1, the screw tabs fractured intra-operatively.Surgery was successfully completed with a 30 to 40 minute delay.No adverse consequences or medical intervention were reported.
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Search Alerts/Recalls
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