Model Number Fibula Cutting Guide with Implant Placement |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2021 |
Event Type
Injury
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Event Description
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For a vsp reconstruction procedure, the surgeon identified an error documented in the 3d systems case report.The plan b vsp reconstruction surgical plan documented the plan a fibula guide in one of the images.
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Manufacturer Narrative
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This issue was identified by the surgeon during surgery, but did not contribute to any significant surgical delay.3d systems verified that the manufactured hybrid fibula cutting guides for both plan a and plan b were designed to the correct surgical plans, respectively; and the issue was isolated to a case report documentation error.3d systems corrected the case report and submitted a new revision to the surgeon during surgery.The surgical outcome was successful with no reported adverse effects to the patient.
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Event Description
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For a vsp reconstruction procedure, the surgeon identified an error documented in the 3d systems case report.The plan b vsp reconstruction surgical plan documented the plan a fibula guide in one of the images.
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Manufacturer Narrative
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This issue was identified by the surgeon during surgery, but did not contribute to any significant surgical delay.3d systems verified that the manufactured hybrid fibula cutting guides for both plan a and plan b were designed to the correct surgical plans, respectively; and the issue was isolated to a case report documentation error.3d systems corrected the case report and submitted a new revision to the surgeon during surgery.The surgical outcome was successful with no reported adverse effects to the patient.
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Search Alerts/Recalls
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