ASTM standard F1798-97 provides guidelines for evaluating the strength of interconnection mechanisms used in pedicle screws and hooks. A literature search indicates the following as common significant clinical complications: fractured pedicle screws; fractured rods; disconnection between the rods, bolts, nuts and screws; screw loosening; loss of correction; inaccurate screw placement; broken pedicles; dural leaks; infection; transient and permanent neural injury. The tests outlined in ASTM standard F1798-97 may correspond to disconnection between the rods and screws or loss of correction. The standard does not correspond to any other known causes of the common complications. Therefore, interconnection strength tests may not have any bearing on the clinical outcomes of patients since there is no direct evidence that they sufficiently test for relevant device failures.
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