Catalog Number UNK_OFL |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Wound Dehiscence (1154)
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Event Date 01/03/2024 |
Event Type
Injury
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.
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Event Description
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It was reported through the stryker facebook page, "i might like to follow up with you as well.I've now had both my hips done this way, but the "anchor pins" incisions are still not healed from my october 12 surgery" this pi is for the patient's right hip.
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Event Description
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It was reported through the stryker facebook page, "i might like to follow up with you as well.I've now had both my hips done this way, but the "anchor pins" incisions are still not healed from my october 12 surgery." this pi is for the patient's right hip.
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Manufacturer Narrative
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An event regarding infection involving a unknown mako unknown was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the lot details were not provided.-complaint history review: could not be performed as the lot details were not provided.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : not available.
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Search Alerts/Recalls
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