NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number PS10.0-50SJ235 |
Device Problems
Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
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.The reported event has been addressed in the device labeling.
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Event Description
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Information was received via literature that the patient had localized osteolysis at the level of the nail¿s telescopic junction which is clearly atypical and potentially implant-related.Additionally, osteolytic zone at the distal locking bolts and at the tip of the nail.
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Manufacturer Narrative
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Corrected data: b2.Additional data: a4, b1, b5, b7, d8, h6.
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Event Description
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Additional information was received that the patient had lytic osteolysis and reported pain during consolidation.Additionally, it was reported that the implant had a corrosive stain.
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Manufacturer Narrative
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Additional data.
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Event Description
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N/a.
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Search Alerts/Recalls
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