(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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The following was reported: correction of scoliosis; dr (b)(6), (b)(6) hospital, (b)(6) 2018.Primary performed in (b)(6) 2017.Reason for revision: both rods had jumped the screws and set screws.Post case, patient fell twice - after second fall, patient had x-ray and both rods were noticed to have jumped the sai screws.Dr (b)(6) took patient back to theatre (b)(6) 2018 to lock down both rods in to the insitu sai screws.At time of removing inner set screws of both insitu sai screws - he commented that possibly the set screws may not have been 'final tightened'.Dr (b)(6) took full responsibility for not locking down the set screws during the primary case.Dr (b)(6) has been made aware that a product complaint would be completed.Revision case today went well with no complications.Jnj representative was not present at case.
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