Model Number 3001-05535 |
Device Problems
Fracture (1260); No Apparent Adverse Event (3189)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/02/2020 |
Event Type
malfunction
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Event Description
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It was reported that the inner collet of 3 mesa sm stature deformity polyaxial screws broke during reduction of the rail intra-operatively.The screws were removed and replaced.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will represent the third of three screws.
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Event Description
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It was reported that the inner collet of 3 mesa sm stature deformity polyaxial screws broke during reduction of the rail intra-operatively.The screws were removed and replaced.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will represent the third of three screws.
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Manufacturer Narrative
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Visual inspection: the returned screw was not fractured; however, the inner collet had deformations around its tab.Scratching can be seen around the outer collet.Functional inspection: the screw was functionally inspected and the inner and outer collet were able to partially/final lock using corresponding instrumentation.No abnormalities were found.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Upon inspection of the returned device, the alleged failure mode could not be confirmed as the device was not fractured.The inner collet had loss of anodization around its tab which could have resulted from difficulty attaching/detaching the reduction instrument during the procedure.The observed loss of anodization does not impact functionality of the device.The screw was able to attach to a reduction instrument and was also able to partially/final lock with a locker.No device issues were found.
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Search Alerts/Recalls
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