Device analysis performed on the returned indirect decompression (id) spacer revealed that the spindle cap was partially sheared off from the implant body and severe abrasion was observed on the mating surface of the actuator.This damage indicates excessive force was likely used during the procedure.Damage to the device prevented functional testing.However, this damage to the spacer indicates the break was due to deployment against resistance, such as bone, and/or manipulation of the position of the device by shifting 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 and is noted within the ifu as a potential complication associated with use of the device.
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