LEVO STANDARD PACKAGE

Additional Manufacturer Narrative

PER THE INFORMATION OBTAINED FROM THE INVESTIGATION, IT WAS CONFIRMED THAT THE REPORTED LACERATION INJURY WAS CAUSED BY NON-MIZUHO ORTHOPEDIC SYSTEMS (DBA-MIZUHO OSI) DEVICES (SKULL CLAMP AND SKULL PINS) MOUNTED ON MIZUHO OSI DEVICE. MIZUHO OSI DEVICE PERFORMED AS INTENDED WITHOUT ANY ISSUES. WHILE THERE WERE NO FUNCTIONAL ISSUES REPORTED WITH THE SKULL CLAMP AND SKULL PINS (NON-MIZUHO OSI DEVICES), THESE DEVICES ARE PLANNED TO BE RETURNED TO THE LEGAL MANUFACTURER (PRO MED INSTRUMENTS GMBH/BLACK FOREST MEDICAL GROUP) FOR FURTHER ANALYSIS AND EVALUATION. THE REPORTED PATIENT INJURY IS SUSPECTED TO HAVE BEEN CAUSED BY A NON-MIZUHO OSI DEVICE DUE TO ITS USAGE NOT ACCORDING TO THE ESTABLISHED SPECIFICATIONS. SKULL CLAMP WAS SUSPECTED TO BE NOT SEATED PROPERLY THUS CAUSING THE SKULL PINS TO MOVE AND LACERATE THE PATIENT'S SKULL. THE ROOT CAUSE OF THIS INCIDENT IS THUS DEEMED AS USE ERROR.

Description of Event or Problem

DURING THE SURGICAL PROCEDURE, THE DEVICE WAS APPLIED TO THE PATIENT AND THE OPERATOR CONFIRMED A PINNING PRESSURE OF 80 LBS. WHEN REPOSITIONING OF THE PATIENT'S HEAD WAS ATTEMPTED, THE PATIENT WAS OBSERVED TO HAVE SLID INTO A DIFFERENT POSITION RELATIVE TO THE DEVICE. THE PROCEDURE WAS COMPLETED; HOWEVER, UPON CONCLUSION A 2-3 INCH LACERATION WAS NOTED ON THE POSTERIOR ASPECT OF THE PATIENT'S HEAD.