Model Number P99-150-0025 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Identifying information, such as the lot number of the device was not reported to paragon 28.Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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Event Description
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Two depth gauges was reported not measuring accurately.The monster screw system (p99-150-0025) depth gauge was said to be measuring 2 mil short and 3 mil short.The baby gorilla/gorilla plating system (p99-150-0014) was said to be measuring 4 mil short.Due to limited information, potential of harm is based on worst case-scenario for the failure mode, independent of a condition failure.This is report 1 of 2 for this incident.
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Event Description
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Three depth gauges were reported not measuring accurately.The monster screw system (p99-150-0025) depth gauge was said to be measuring 2 mil short and 3 mil short.The baby gorilla/gorilla plating system (p99-150-0014) was said to be measuring 4 mil short with the tip sticking out.Due to limited information, potential of harm is based on worst case-scenario for the failure mode, independent of a condition failure.This is report 1 of 3 for this incident.
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Search Alerts/Recalls
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