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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