Methods: material analysis was performed and each rod was found to have fractured in bending fatigue as a result from the rod contact with another implant.Device history records were reviewed and all released units met specification.Elemental composition of the material confirms with the drawing.Results: the customer reported event was confirmed based on visual inspection of the returned devices.The elemental constituents were as specified on the print.No material or manufacturing defects were found.No similar complaints for the reported lot number were identified.Conclusion: the reported event occurred when the patient was putting backpack on their back.The plausible root cause is sudden impact leading to overload of the construct and assembly of construct producing large bending moment and loads on the device due severe deformity.The ifu state that, "the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device 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 device.".
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