The returned spacer was analyzed and revealed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force.The damage to the implant indicates the break was likely due to deployment against resistance, such as bone, and or manipulation of the position of the device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, it states should any resistance be encountered during deployment of the superion implant, it may be suggestive of interference between the implant and bony anatomy, e.G., lamina, hypertrophic spinous process, and, or suboptimal implant positioning.Do not attempt to manipulate the position of the device by gear-shifting the inserter, i.E., gross cranial, caudal, lateral articulation, fig.8h, as the mechanical advantage or leverage provided by the length of the inserter may be sufficient to damage the implant or surrounding anatomy and are among the risks associated with the procedure.
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