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.
The paper present the historical Danish approach for fault and interruption statistics within the ELFAS cooperation. From January 2013 ELFAS have introduced a revised set of guidelines and recommendations on registering detailed component and customer information for detailed fault and outage statistics for future use in asset management and in a more detailed view on continuity of supply.
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