Device evaluation: the rod was returned to nuvasive for evaluation.Upon visual inspection of the rod, scoring marks on the distraction rod were observed which are generally associated with incremental distractions.The presence of black debris was observed between the surfaces of the distraction rod and the housing tube.In-house x-rays revealed that the distraction rod and lead screw were not concentric with respect to the housing body.In addition, the distraction rod appeared to be contacting the inner surface of the housing tube, which is a possible reason for the score marks on that side of the distraction rod.X-rays also discovered a broken radial bearing.The rod was then sectioned, and the o-ring was examined.The o-ring was found torn and the housing tube¿s grove was worn down from the distraction rod rubbing on the inner surface.It is possible that the presence of external bending forces on the rod could have led to the scoring and by extension the generation of metal debris.These external bending forces could have also caused the distraction rod to have unequal compression on the internal o-ring, which can result in a torn seal.A compromised seal can lead to a broken bearings as bodily fluids ingress into the internal mechanism, increasing the friction on the bearing.Due to the broken bearing, functional testing was not possible.No patient x-rays or blood work results were provided, therefore, the reported metallosis could not be confirmed.However, wear debris was confirmed visually as it was found on the device upon return.The black debris that was found is likely titanium debris caused by friction during use.
|