NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number UNKNOWN |
Device Problem
Material Discolored (1170)
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Patient Problems
Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device was not made available for evaluation and the device lot number was not provided.The root cause is unable to be determined.If any relevant additional information is provided, a supplemental report will be submitted.Literature citation: rolfing, jan duedal, et al (2021).Pain, osteolysis, and periosteal reaction are associated with the stryde limb lengthening nail: a nationwide cross-sectional study.Acta orthopaedica, volume 92.Web address to article: https://doi.Org/10.1080/17453674.2021.1903278.
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Event Description
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Information was received via review of literature that a patient experienced osteolysis and hypertrophy.Additionally, at removal, nail discoloration was noted.No additional information is available.
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Search Alerts/Recalls
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