Model Number 209999 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 02/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplement al report will be submitted when additional information becomes available.
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Event Description
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This pi is for patient 1 of 3.(b)(6) yo male, surgery (b)(6) 201 9.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.
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Manufacturer Narrative
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Update to d2.Reported event: it was reported ¿this pi is for patient 1 of 3.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.¿ method & results: product evaluation and results: a review of the case logs did not find anything that would suggest issue with the robotic system.The patient plan and resection visuals did not show anything out of the ordinary.All accuracy values for bone registration were acceptable and the registration pattern was properly taken.Product history review: a review of device history records shows that (b)(6) was inspected on (b)(6) 2009 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a search of the complaint database under device identification pn: 209999 reports no similar complaints for pka software, other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.A review of the case logs did not find anything that would suggest issue with the robotic system.The patient plan and resection visuals did not show anything out of the ordinary.All accuracy values for bone registration were acceptable and the registration pattern was properly taken.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.
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Event Description
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This pi is for patient 1 of 3.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucence es underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation n and my results seem to be much better.Case type: pka 3.0.
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Search Alerts/Recalls
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