LEVO ARM HEAD POSITIONING SYSTEM

Description of Event or Problem

PT WAS SECURED IN MAYFIELD PINS AND LEVO PRONE ATTACHMENT AT THE BEGINNING OF SURGERY. SURGERY TEAM WAS NEAR THE END OF CERVICAL FUSION. WHILE SCREWING IN SET CAPS, THE SURGEON NOTED THAT THE PT'S HEAD DROPPED SIGNIFICANTLY. THE SURGEON, CIRCULATING NURSE, AND CRNA BEGAN INVESTIGATING AND FOUND THAT THE LEVO ARM WAS LOCKED TO BOTH THE BASE, AND PT'S HEAD VIA MAYFIELD ATTACHMENT. HOWEVER, THE ARM WAS NOT HOLDING ITS POSITION AS IT SHOULD, IT WAS COMPLETELY LIMP AND MOVEABLE WITHOUT PRESSING EITHER RELEASE BUTTON. THE PT'S CHIN WAS RESTING ON THE CHEST PILLOW OF THE JACKSON PRONE BED. THE ARM WAS FOUND TO BE DRY, COVERED WITH A SLEEVE FOR PROTECTION DURING SURGERY, AND THE GREEN CHARGED LIGHT WAS LIT. THE SURGEON STABILIZED THE PT'S HEAD WHILE THE CIRCULATING NURSE REPLACED THE MALFUNCTIONING ARM WITH A DIFFERENT LEVO ARM. THE PROCEDURE WAS THEN COMPLETED WITHOUT FURTHER COMPLICATION. THE PT DID NOT HAVE ANY ADVERSE OUTCOMES FROM THIS EVENT. THIS FACILITIES LEVO ARM'S WERE RECENTLY EXCHANGED THROUGH THE MFR FOR A VOLUNTARY RECALL. THE MALFUNCTIONING UNITS QA REPORT WAS REQUESTED FROM THE MFR, AND IT WAS DETERMINED UPON REVIEW THAT THIS UNIT FAILED ITS QA PRIOR TO SHIPMENT AND SHOULD NOT HAD BEEN RELEASED FOR USE. ALL THREE LEVO ARMS AT THIS FACILITY HAVE BEEN RETURNED TO THE MFR. FDA SAFETY REPORT ID# (B)(4).