The product was returned and tested according to specifications.No radiographs or images were provided to confirm the alleged event.As per reporter the band positioning was higher than intended and recommended creating excessive prying force.Even though root cause cannot be confirmed, root cause may be related a procedural error.Follow up technique variation has been provided to involved staff.No product failure was identified.Labeling review: ".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Potential risks identified with the use of this system, which may require additional surgery, include: ¿ disassembly, fraying, kinking, loosening, bending or breakage of any or all of the versatie system implant components ¿ loss of fixation ¿ nonunion or delayed union ¿ fracture of the vertebra." ".Step 1: create spinous process hole use the provided bone punch or 3.5 mm burr to create a hole in the spinous process once the screws are placed, prior to inserting the rod.Once the hole has been created, the rod can then be placed (fig.9).Step 2: load connector reference sub-laminar fixation step 1.Step 3: pass band pass the needle tip of the band through the newly created hole.Use the needle driver to grip the thick rope portion (not the needle), and pull the band laterally through until both ends are even (fig.10).Tip when using the bone punch, place the tips on either side of the spinous process as ventral as possible, squeeze the arms, and rock the instrument in the cranial/caudal direction to create a through hole.".
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