Device analysis performed on the returned superion indirect decompression spacer revealed that the spindle cap was completely separated from the implant body.Damage to the device prevented functional testing; however, this damage to the spacer indicates the break was due to deployment against resistance.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 and is noted within the ifu as a potential complication associated with the use of the device.
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