Model Number 403001-05 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that when navigating the cup the version and abduction outputs were incorrect.The version of the cup and abduction were confirmed to be correct by the surgeon intraoperatively using c-arm.Once the product is returned, orthalign, inc.Will perform an investigation into the alleged accuracy issue.Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that could be caused to the patient by an inaccurate device measurement.
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Event Description
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It was reported that when navigating the cup the version and abduction outputs were completely incorrect.The version of the cup and abduction were confirmed to be correct by the surgeon intraoperatively using c-arm.
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Manufacturer Narrative
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A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.
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Search Alerts/Recalls
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