The returned spacer was analyzed and revealed that the spindle cap was completely sheared off from the implant body and the actuator shaft and spindle found to be outside of the main body.Additionally, severe abrasion was observed on the mating surface of the actuator.Damage to the device 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 device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use ifu product label.Additionally, it states do not force deployment or implant breakage or damage to bony structures may result, and should any resistance be encountered during deployment of the superion implant, it may be suggestive of interference between the implant and bony anatomy e.G., lamina, hypertrophic spinous process, and - or suboptimal implant positioning among other risks associated with the procedure.
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