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Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained because the device associated with this event was not returned.From the xia ifu: the surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.Patients who are overweight may be responsible for additional stresses and strains on the device which can speed up metal fatigue and/or lead to deformation or failure of the implants.The size and shape of the bone structures determine the size, shape and type of the implants.Once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidated.This may result in further side effects or necessitate the early removal of the osteosynthesis device.There is not enough information to determine a root cause.Possible root causes include under-tightening of the blocker, over-tightening of the blocker, excessive patient post op activity, patient fall, poor bone quality, improper rod bending, offloading of the blocker, patient non fusion, implant used past its usable life, and/or poor fixation construct.
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