Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the xia 3 stg: there are two options for preparing the site and inserting the hook: option 1: a horizontal window is created by excising the ligamentum flavum combined with the limited osteotomy of the edge of the lamina.The window is prepared large enough to accommodate the blade of the hook to be inserted.The blade is then turned 90° and seated on the lamina.Option 2: a squared window is created by opening the ligamentum flavum in conjunction with the limited laminotomy.A lamina preparer may be used with great care to dissect the ligamentum flavum.The hook is inserted in a downward rotational movement so that the tip of the blade hugs the anterior surface of the lamina at all times.Note: a gentle burring of the lamina is sometimes necessary to ease the access to the canal.As the device was not returned, a definite root cause cannot be determined.From the rep, it is possible excessive force was applied when installing the rod that could have contributed to the event.Other possible root causes include unintended bending/cantilever force applied during hook insertion, insufficient preparation for hook installment, incorrect instrument used, incorrect path/window created, and/or deformed/damaged blade tip.H3 other text : device was discarded by the site.
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