On 20 july it was added the lot of the instrument is unknown.On 26 july 2018 the r&d project manager made the following analysis: difficulty to engage the set screw into the pedicle screw head (tulip), after rod reduction.The issue is confirmed by attempting to place the set screw without the rod.The issue can be caused by a defect of the thread of the tulip.However the same thread is used to couple the screw to the pedicle screwdriver at the first steps of the surgery, therefore the thread cannot have been defective from the beginning.The defect/deformation could have occurred during the reduction manoeuvre/first attempt to engage the set screw.Or the defect can be on the set screw.Detailed analysis will be performed with the devices as soon as available.On 27 july 2018 the medical affairs director made the following analysis: during a percutaneous lumbar posterior stabilization surgery, difficulty was encountered placing the set screw on one of the l5 pedicle screws, which was therefore removed and exchanged.No further problem was encountered.We do not think that the cause for this inconvenience can be of clinical origin.No clinical consequence should be expected apart from the surgery being lengthened by approximately 30 minutes, according to the report.Batch review performed on 30 july 2018: lot 1721554: (b)(4) items manufactured and released on 08 june 2018.Expiration date: 2023-04-05.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.The set screw lot has been checked too: (b)(4) items released, with no anomalies related to the issue.
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When the surgeon was trying to insert the set screw into the pedicle screw head which was already implanted at l5, it was not able to insert, even though the surgeon used the reducer.Then he tried to insert without the rod, but it was not able.Since it was doubtful whether the issue was with pedicle screw head or percutaneous tower, the pedicle screw was replaced with a more large size.The surgery was performed by pps and finished successfully.Due to this event the surgery was prolonged about 30 minutes.
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