Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off 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 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 ifu as a potential complication associated with the use of the device.
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