Device Problems
Collapse (1099); Loose or Intermittent Connection (1371)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not available for evaluation as it remains in the patient.No determinations can be made as to the cause of the reported issue.
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Event Description
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It was reported that revision was done due to creo mis screw which loosened post operatively with subsequent cage collapse.This event occurred in (b)(6).
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Manufacturer Narrative
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The device was not available for evaluation as it remains in the patient.The imaging provided show screw migration relative to the superior vertebral body of the instrumented level, however the construct itself appears to remain rigidly assembled.However, no determinations can be made as to the cause of the reported issue.
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Event Description
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It was reported that revision was done due to creo mis screw which loosened and cage subsidence post-operatively.This event occurred in austria.
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Search Alerts/Recalls
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