Adult female patient presented to or for chiari decompression/microdissection.Mayfield skull clamp/skull pins were placed with patient supine on stretcher.When patient was turned to the prone position bleeding was noted from the left side of the head.The patient was immediately returned to the supine position on the stretcher so that the surgeon could investigate the cause of the bleeding.The surgeon stated that the skull pins had slipped, resulting in a scalp laceration approximately 2.5 inches long on the left side of the patient's head.The mayfield skull clamp was immediately sequestered.The surgeon closed the laceration with staples, a replacement device was obtained, and the patient was repositioned without incident.Surgery then proceeded as planned.The mayfield skull clamp was shipped to the manufacturer for evaluation/repair.The repair report notes that the index knob was loose and easy to turn.The device passed all other functional tests.Manufacturer response for mayfield modified skull clamp, mayfield (per site reporter): repair report states that the complaint was confirmed via inspection of the unit.The index knob was loose and easy to turn.The clamp passed all other functional testing.
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