Model Number SD980.001 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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Investigation ongoing; rc unknown.
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Event Description
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Trumatch maxillary plate did not fit patient anatomy.The planned advancement was not reached.Revision surgery needed.
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Manufacturer Narrative
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Investigation concluded that the devices met specifications and did not malfunction.No root cause could be established for the plate fitting issue.
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Event Description
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Trumatch maxillary plate did not fit patient anatomy.The planned advancement was not reached.Revision surgery needed.
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Search Alerts/Recalls
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