B1 has been updated from "adverse event and product problem" to "adverse event" h6, device code, has been updated from "fracture" to " adverse event without identified device or use problem".Visual, dimensional, material and functional analysis could not be performed as the device was not returned. device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Device sgt and ifu were reviewed: "for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body screw insertion: with the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended.Implant selection and use the choice of proper shape, size and design of the implant for each patient is crucial to the success of the surgery.The surgeon is responsible for this choice which depends on each patient.Adverse effects.Intraoperative fissure, fracture, or perforation of the spine can occur due to implantation of the components.Postoperative fracture of bone graft, the intervertebral body, pedicle, and/or sacrum above and/or below the level of surgery can occur due to trauma, the presence of defects, or poor bone stock." for larger diameter screws, there is more torque applied at the upper part of the screw due to the cancellous cortical thread design combined with a dual lead.Under-tapping may cause the screw to become bound in the bone, and with the excess torque applied to drive the screw down, may cause the pedicle to fracture.Possible root causes include lack of tapping, under tapping, difficult angle, and/or excess torque applied.However, as no additional information was received from the field or and the product is still implanted in the patient, the root cause could not be determined conclusively.
|