The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation identified that the unit was received without the 80lb torque knob.The unit passed all specific functional testing requirements, except for the lock having rotational movement when the unit is not under pressure, this would not have caused a slippage.General maintenance and cleaning were performed.Root cause: the functional testing of the device could not duplicate the reported complaint.Unit received without 80lb torque knob.The returned unit passed all specific functional testing requirements and the slippage could not be duplicated.When the unit is properly positioned and put under pressure unit would not have slipped.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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A facility reported that during posterior cervical fusion c1-c4 procedure, the surgeon felt that the mayfield modified skull clamp (a1059) slipped.No patient injury was noted.However, a change of patient alignment was observed via intraoperative x-ray.Additional information has been requested on the results of the x-ray.
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