LENKE PEDICLE PROBE

Description of Event or Problem

DURING SPINAL FUSION SURGERY, LENKE NAVIGATION PROBES WERE USED. THE PATIENT HAD A PREEXISTING CONDITION (DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS) WHICH MADE THE BONE OF THE VERTEBRA DENSE. IN THE ATTEMPT TO PLACE PEDICLE SCREWS, THE TIP OF TWO LENKE PROBES FRACTURED. THE FRAGMENTED INSTRUMENTATION WAS UNABLE TO BE SAFELY REMOVED, BUT OPINED TO BE IN A PLACE OF SAFETY, EXTREMELY UNLIKELY TO MIGRATE INTO A DANGEROUS POSITION. FDA SAFETY REPORT ID# (B)(4).