Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body and the actuator shaft and spindle were found to be outside of the main body as well as tool damage to the body of the implant.This damage to the implant prevented functional testing.However, this damage to the spacer indicates the break was likely 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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