This is 2 of 2 reports linked to mfg report number 3004608878-2023-00246: medwatch report# 3000030000-2023-8004 was received with the following information: ''mayfield skull clamp was placed on patient.The torque knob was tightened to 40lbs of force and the locking mechanism was locked.Patient was then placed prone and positioned using gel rolls.When the head was flexed by way of the head clamp, the locking mechanism failed.The pin slipped on the patient's head, causing a 2" scalp laceration.If the pin would have slipped completely, the head would not have been supported, risking a high cervical injury.The scalp laceration was sutured after we returned the patient in the supine position the hospital bed.We attached another clamp and manipulated the head in the same way, with the same result.The second head clamp was removed and the remainder of the procedure was done with the head on a cerebellar headrest.The two devices involved were sn [redacted number] and [redacted number], but it¿s unknown which device was used first or second.¿¿.
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The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - the returned unit could not be evaluated because it is beyond integra¿s 10-year service lifecycle and cannot be repaired.Additionally, due to lack of further information received, we are unable to perform a complete investigation.Root cause - the definite root cause cannot be identified as the device was not serviceable.Based on the reported complaint, probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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