REVIEW OF DHR DID NOT FIND ANY DEVIATIONS OR ABNORMALITIES. REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS ON THIS ITEM FOR BREACHES RESULTING IN REVISION. REVIEW OF RETURNED PRODUCT DETERMINED THAT THE RETURNED PRODUCT WAS WITHIN SPECIFICATIONS. THE FINAL ROOT CAUSE DETERMINATION WAS IDENTIFIED TO BE USER ERROR IN PLACEMENT OF THE GUIDE. THIS ROOT CAUSE WAS CONCLUDED BASED ON DISCUSSIONS WITH THE SURGEON USING THE GUIDE, BONE MODEL AND POST-OP CT SCAN. NO FURTHER ACTIONS ARE REQUIRED.
D
Patient 1
IT WAS REPORTED THAT DURING THE PATIENTS INITIAL POSTERIOR SPINAL FUSION OPERATION USING FIREFLY PATIENT-SPECIFIC PEDICLE SCREW GUIDE, WHILE USING THE L4 GUIDE ON THE L4 LEVEL IN THE PATIENT, THE LEFT SCREW WAS PLACED LATERALLY AND THE RIGHT SCREW WAS PLACED MEDIALLY. FURTHERMORE, THE PATIENT PRESENTED WITH PAIN AND RADICULOPATHY TWO WEEKS POST-OP AND REQUIRED A REVISION PROCEDURE TO REPOSITION THESE SCREWS.