Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.During the revision surgery it was discovered that both sides of the connector were disconnected from the diapason rod.It was reported that the load on the connector of the axial part was released and the rod came off from the connector.Additional rods were added to each left and right sides and four parallel rods were used.The rod that disengaged from the connector remains implanted.Since the rod migration was noticed approximately two years after the initial surgery and the patient did not fuse the most likely cause of the reported event is delayed healing.Per the surgical technique: delayed union or nonunion - internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.
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