Analysis of the returned indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body, and actuator shaft and spindle were found to be outside of the main body.The damage to the implant indicates the break was likely due to deployment against resistance 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.Additionally, labeling states to not force deployment or implant breakage or damage to bony structures may result.Therefore, boston scientific concludes the probable cause of the reported event was unintended use error caused or contributed to event.
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