RELINE

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON INSERTED SPINAL CAGE BETWEEN THE L4/L5 VERTEBRAE USING THE PLIF METHOD, AND PERFORMED POSTERIOR FIXATION AT THE L4/L5 VERTEBRAE. THREE WEEKS AFTER SURGERY, THE SPINAL ROD DISLODGED FROM THE SPINAL SCREW INSERTED INTO THE RIGHT 5TH LUMBAR VERTEBRA. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.