Catalog Number 180733-1 |
Device Problems
Device Operates Differently Than Expected (2913); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Surgeon attempted to put the poly in and it would not lock.After examining it, the base of it was not flat and therefore wouldn't lock into the base plate.Surgical delay of 5 to 7 minutes.Case type left pka.
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Manufacturer Narrative
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An event regarding alleged seating/locking issue involving a mako insert was reported.The event was not confirmed.The device was returned in used condition.The scratches and gouges were observed throughout the device.Examination of the device by the material analysis engineer indicated that damage observed consistent with implantation process.-medical records received and evaluation: not performed as no medical records were provided.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The event reported for base of the insert was not flat and therefore wouldn¿t lock into the base plate.The event was not confirmed due to no functional or dimensional inspection conducted since the device found damaged.The returned device showed scratches and gouges throughout the device.Examination of the device by the material analysis engineer indicated that damage observed consistent with implantation process.No further investigation for this event is required at this time.If the additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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Surgeon attempted to put the poly in and it would not lock.After examining it, the base of it was not flat and therefore wouldn¿t lock into the base plate.Surgical delay of 5 to 7 minutes.Case type left pka.
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Search Alerts/Recalls
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