Device analysis performed on the returned spacer revealed that the spindle cap was completely sheared off from the implant body.Damage to the device prevented functional testing, however, this damage to the spacer indicates the break was due to deployment against resistance.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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