NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Liver Damage/Dysfunction (1954); Pain (1994); Non-union Bone Fracture (2369); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/01/2021 |
Event Type
Injury
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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 patient reported experiencing pain, bony abnormalities, non-union of the tibia, ovarian cysts, liver issues, and chromium toxicity.No additional information was provided.
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Search Alerts/Recalls
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