It was reported that the during a superion indirect decompression system implant procedure, the implant would not open correctly.It was noted that there was damage to the screw.The physician tried to remove the driver and reinsert the implant, but the attempt was unsuccessful.There were no patient complications.
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It was reported that the during an indirect decompression (id) system implant procedure, the implant would not open correctly.It was noted that there was damage to the screw.The physician tried to remove the driver and reinsert the implant, but the attempt was unsuccessful.There were no patient complications.
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The returned spacer was analyzed and revealed that the spindle cap was partially sheared off from the implant body.The partial detachment of the spindle cap was due to excessive force.The damage to the implant indicates failure was likely due to deployment against resistance (e.G.Bone) and/or manipulation of the position 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, which states not to force deployment or implant breakage or damage to bony structures may result.Additionally, the ifu states that should any resistance be encountered during deployment of the implant, it may be suggestive of interference between the implant and bony anatomy (e.G.Lamina, hypertrophic spinous process, etc.), and/or suboptimal implant positioning.Do not attempt to manipulate the position of the device by gear-shifting the inserter (i.E.Gross cranial/caudal/lateral articulation), as the mechanical advantage/leverage provided by the length of the inserter may be sufficient to damage the implant or surrounding anatomy.
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