CLARIANCE SAS

Description of Event or Problem

THE PLATE WAS ATTACHED TO THE ALIF CAGE AND PLACED ON THE INSERTER. UPON IMPACTION OF THE CAGE INTO THE DISC SPACE BOTH OF THE BOTTOM LOCKING RINGS ON THE PLATE BECAME LOOSE AND DISENGAGED FROM THE PLATE. THIS HAPPENED DURING THE PLACEMENT OF THE CAGE AND BEFORE THE SCREWS WERE INTRODUCED. ACCORDING TO THE SURGEON AND THE REPRESENTATIVE PRESENT DURING THE CASE, THERE WAS NOTHING OUT OF THE ORDINARY THAT TOOK PLACE AND NO EXCESSIVE FORCE WAS USED. THE SURGEON REMOVED THE LOOSE RINGS WITH PICK-UPS AND SECURED THE CAGE TO THE L5 VERTEBRAL BODY USING TWO SCREWS WITHOUT SECURING THE PLATE TO S1. THE TWO DISENGAGED RINGS WERE DISPOSED OF INTO THE SHARPS CONTAINER BEFORE THE REPRESENTATIVE COULD SECURE THEM TO BE SENT BACK FOR EVALUATION. NO INJURY TO THE PATIENT OR SIGNIFICANT DELAYS WERE REPORTED.

Additional Manufacturer Narrative

IT WAS REPORTED TO US THAT DURING IDYS-ALIF TIVAC SURGERY, UPON IMPACTION OF THE CAGE AND PLATE INTO THE DISC SPACE, TWO LOCKING RINGS SEPARATED FROM THE PLATE. THE TWO RINGS WERE RETRIEVED BY THE SURGEON. AS A CONSEQUENCE, 2 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WILL BE IMPLANTED. THIS EVENT IS REPORTABLE AS A MALFUNCTION.