Model Number UNKNOWN |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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Information was received that the nail was noticed to have a visible bend.No patient harm was reported.
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Manufacturer Narrative
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Visual inspection of the returned nail revealed evidence of discoloration.Per reported failure, functional testing was not applicable.Utilizing external assessments and standard corrosion test methods (salt spray), investigation has identified mechanically assisted crevice corrosion (macc) as the likely direct cause.Review of device history records reveal that the rod was visually inspected and functionally tested prior to release.
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Event Description
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No additional information provided.
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Event Description
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No additional information provided.
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Manufacturer Narrative
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The follow up report submitted on september 30, 2021 providing a device evaluation was incorrect.The device was not returned for evaluation.The manufacturer contacted the customer to inquire about the return of the product but has yet to receive anything related to this complaint.The expected date of return for the device/component is unknown, thus no failure investigation can be performed and no root cause can be determined.In the event the device/component does return to nuvasive, this complaint will be reopened and reviewed for further processing.
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Search Alerts/Recalls
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