Device analysis performed on the returned superion indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body.This damage to the id spacer indicates the break was due to both the deployment against resistance, such as bone, and not correctly attaching the inserter to the spacer.A labelling review was performed, and it did not reveal any anomalies.Additionally, device breakage can occur when used with forced deployment and is noted within the instructions for use (ifu) as a potential complication associated with the use of the device.
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