Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.Damage to device indicates the breakage was due to a combination of deployment against resistance such as bone, and failing to correctly attach the inserter to the spacer.A labelling review was performed and it did not reveal any anomalies.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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