It was reported that the indirect decompression (id) spacer was dropped in the operating room (or) and there was no device issue.Device analysis was performed on the returned implant and revealed that the spindle cap was completely sheared off from the implant body and there was severe abrasion on the mating surface of the actuator.This damage to the implant indicates the break was due to both the deployment against resistance, such as bone, and not correctly attaching the inserter to the spacer.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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