Model Number 482317540 |
Device Problems
Material Separation (1562); 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 05/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device remains implanted.
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Event Description
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It was reported that the tulip of a xia 3 polyaxial screw broke off from the screw shaft post-operatively.Revision surgery has not been scheduled or performed at this time.
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Event Description
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It was reported that the tulip of a xia 3 polyaxial screw broke off from the screw shaft post-operatively.Revision surgery has not been scheduled or performed at this time.
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Manufacturer Narrative
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The device remains implanted and therefore unavailable for evaluation.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 and no adverse trends were identified.The event of tulip disengagement was confirmed via imaging provided by the reported physician.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A definitive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.
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Search Alerts/Recalls
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