Device analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number; similar complaints were identified.Although the devices remains implanted and can therefore not be analyzed, x-ray imaging was provided by the field.Construct migration cannot be confirmed in the provided imaging.Similar construct design x-rays from the same surgeon for the same failure mode were reviewed by a consultant spine health care provider.The physician believes that the construct design with difficult deformities was the most likely contributing factor to the event.The operating surgeon used a low density screw construct which ended on the convex curve of the spinal deformity.The low screw density and short length of construct, along with possible loss of correction, may not have been enough to counter the force of the spine trying to revert to its original position.This may result in eventual failure at the distal most screw (where biomechanical loading is most likely greater) leading to the rod slipping from the screw.Additionally, the construct was implanted in 2019 and has been in place for over three years.From the ifu: "internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant." h3 other text : device location is unknown.
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