Medtronic—KYPHON Directional Bone Void Fillers: Directional Arrow at Proximal End May Not Align with Cutout Opening on Distal End

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In a May 17, 2017, Urgent Field Corrective Action letter submitted by ECRI Institute member hospitals, Medtronic states that directional arrow at the proximal end of the above instruments may not correctly align with the cutout opening on the distal end of the instrument, potentially leading to injected cement being placed in a direction unintended by the surgeon. Medtronic also states that risks associated with this misalignment include cement extravasation into the spinal canal with a potential result of paralysis or nerve injury with risk of pulmonary embolism or cardiac arrest. Medtronic further states that it has received 2 reports of misalignment; however, it has received no reports of patient injury related to this problem. The manufacturer has not confirmed...