Device analysis performed on the returned superion indirect decompression spacer revealed that the spindle cap was partially sheared off from the implant body.The partial detachment of the spindle cap was due to excessive force.This damage to the spacer indicates the failure was likely due to both deployment against resistance, such as bone, and 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, device breakage can occur when used with forced deployment as noted within the ifu as a potential complication associated with the use of the device.
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