NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number PS11.5-65B250 |
Device Problem
Material Discolored (1170)
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Patient Problems
Inflammation (1932); Pain (1994); Osteolysis (2377)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation.Root cause is unable to be determined at this time.Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.
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Event Description
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Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, the patient experienced a sudden increase in pain and bone abnormalities at the junction of the telescoping nail segments.Upon explant it was noticed that the nail was corroded.No patient injury was reported.
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Event Description
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Additional information was received via review of literature that the patient experienced swelling, osteolysis and periosteal reaction.
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Manufacturer Narrative
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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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