Information was received from healthcare professional via field representative regarding patient with symptoms of opll (ossification of the posterior longitudinal ligament) involved in posterior cervical decompression and fusion procedure.Levels implanted: c2-t3.It was reported that intra-operatively, three out of the 16 set screws were stripped.It was put out a feeler to replace the set screws, but the set screws were stripped and couldn't be removed, so they were continued to be placed.Product was used correctly according to the directions given in the ifu/labeling.Event was associated with patient.There were no patient symptoms or complications reported as a result of this event.There was delay in overall procedure time for less than 60minutes.No health damage in the patient was reported.On (b)(6) 2021 received additional information that, when the set screw placed on the screw was finally tightened, it stripped, and no torque was applied.It was attempted to remove all three stripped products by turning them in the opposite direction, but they could not be removed and continued to be implanted.After stripping occurred, the driver was replaced, but the event was the same.The counter had been used (mas).On (b)(6) 2021 received additional information that product came in contact with the patient.On (b)(6) 2021 received additional information that screwdriver did not cause stripping of screw, it was operated in accordance with surgical technique and the set screw stripped.The driver was not broken.It was tried to remove the set screws about twice but set screws didn't come off.On (b)(6) 2021 received additional information that two if torque limiting drivers were found to be stripped at tips.Both could mate with a sample set screw.On (b)(6) 2021 received additional information that there was no reoperation planned/scheduled.
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