A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Our instructions for use indicate that these implants are not indicated for permanent fixation.They are intended to facilitate arthrodesis of the spine, which was achieved prior to the screw breaking.Although fusion was reported at the l5/s1 level, adjacent "non-fusion" at l4/l5 could contribute to dynamic stresses in the construct.
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