NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number LP4.5-SRF40 |
Device Problems
Corroded (1131); Material Twisted/Bent (2981)
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Patient Problem
Osteolysis (2377)
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Event Date 07/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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Information was received that upon explant the plate was found to have corrosion around the male/female junction.Additionally, it was reported that bridging bone was present and osteolysis and scalloping of the regenerate bone were in close proximity to the corroded plate junction.X-ray images showed a slight bend in the plate.The surgeon believes the corrosion formation may have been assisted by wear debris generated by patient weight-bearing.
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Event Description
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Corrected lot number was obtained.
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Manufacturer Narrative
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Device evaluation: upon return, visual inspection of the plate revealed evidence of discoloration.In addition, osteolysis was visible in the provided x-ray images provided.Per reported failure, functional testing was not applicable.Utilizing external assessments and standard corrosion test methods (salt spray), our investigation has identified mechanically assisted crevice corrosion (macc) as the likely direct cause.The key element has been the mechanical micro-movement within the anti-rotation junction of the stryde devices due to the higher weight bearing potential as a result of a more mobile patient population.We have been able to replicate this in-vitro and have developed the mechanical parameters that drive the clinical variation in corrosion.In-vitro testing has shown a correlation between the load on the telescopic junction of the device and the degree of corrosion, with much less corrosion seen at lower loads.This helps explain why different levels of corrosion between patients as weight bearing protocols vary among surgeons.A root cause analysis was performed and found the risks associated with mechanically assisted crevice corrosion (macc) were not adequately identified and mitigated through the risk management/design control process.Device records review: review of device history records reveal that the rod was visually inspected and functionally tested prior to release.
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Search Alerts/Recalls
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