The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided.Labeling review: "warnings, cautions and precautions: the safety and effectiveness of these devices for any other conditions are unknown.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient" "care should be used in the handling and storage of the reline implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments" "inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the reline implants if there is any evidence of damage" "the silencer and gator reducers are not compatible with reduction screws or reduction uni-planar screws and may damage the implant if used.Only the matador reducer and rocker may be used" "compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system" if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
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It was reported that the patient underwent an initial posterior fixation procedure utilizing percutaneous pedicle screws.During the procedure, following implantation of the pedicle screw, the locking screw was unable to be delivered into the reduction screw tulip.Several lock screws were attempted and none were able to fit.The procedure was converted to an open approach to complete the fixation.No patient harm or further patient impact was reported.
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