NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Device Problems
Material Discolored (1170); Appropriate Term/Code Not Available (3191)
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Patient Problems
Bacterial Infection (1735); Pain (1994)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.Root cause is unknown at this time.
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Event Description
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Information was received that a revision procedure was performed october 8, 2020.As per the reporter, the patient presented lysis, scalloping, and pain post lengthening.X-ray imaging revealed a bony change at the junction of the male and female components of the nail.
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Manufacturer Narrative
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Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.Device evaluation provided by lirc: corrosion scoring: the grading showed a contrast in the evidence of severe corrosion at the extendable junction of one nail compared with mild to no corrosion in the opposite nail.Plain radiographs captured of patient post-implantation pre-removal showed evidence of cortical thickening in bony regions aligned with the extendable junction of the nails.Surface damage - damage within the screw holes was predominately observed in holes 1-3.H3 other text: device returned to lirc.
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Search Alerts/Recalls
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