The complainant reported difficulties reducing a rod into a pedicle screw.The surgeon was unable to use the persuader or the pistol grip reducer.The surgeon was able to reduce the rod using a rod fork.The rod fork was damaged while reducing the rod.There were no known patient complications.The complaint instruments were not returned for complaint assessment.The complainant provided photos of the instruments.The procedure required posterior instrumentation form t9 to l2.Rod contouring for multi-level instrumentation must be performed so that the apex of a bent rod is not in the locking zone of a pedicle screw.The technique guide instructs the end user to verify that the area around the screw to be free of bony protrusions to ensure full engagement of instruments to the pedicle screw.Additionally, the stg instructs that if unable to reduce, consider additional rod contouring, screw relocation or in situ fusion.Dhr reviews for the persuader and rod fork could not be performed, because the lot number was not provided to the company.The dhr for the persuader was reviewed, and there were not manufacturing anomalies.The persuader met all of the required specifications prior to releasing to distributable inventory.
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