INSPAN

Description of Event or Problem

A 14MM IMPLANT DID NOT PERFORM AS INTENDED DUE TO THE DIFFICULT ANATOMY OF THE PATIENT, AND THE DEVICE WAS NOT ABLE TO BE TIGHTENED IN SITU AND HAD TO BE REPLACED. THE SET SCREWS WERE AT NORMAL HEIGHT WITHIN THE IMPLANT ITSELF WHEN RETRIEVED FROM THE CADDY. THE IMPLANT WAS INSERTED INTO THE SURGICAL SITE. THE SURGEON FINAL LOCKED ONE SIDE OF THE IMPLANT THEN ATTEMPTED TO FINAL LOCK THE CONTRALATERAL SIDE. THE INTEGRATED DRIVER IN THE INSERTER KEPT TURNING AND DID NOT FINAL LOCK THE SET SCREW. THE SURGEON LOOSENED THE LOCKED SIDE OF THE IMPLANT AND REMOVED THE ENTIRE IMPLANT FROM THE SURGICAL SIGHT. ANOTHER 14MM IMPLANT WAS SELECTED FROM THE IMPLANT CADDY AND WAS INSERTED AND LOCKED WITHOUT ANY ISSUE. THE SECOND IMPLANT WAS PLACED MORE ANTERIOR THAN THE FIRST PLACEMENT ATTEMPT.

Additional Manufacturer Narrative

DUE TO THE CHALLENGING ANATOMY, THE IMPLANT WAS LIMITED ON THE AMOUNT IT COULD BE COMPRESSED. EVIDENCE ON THE RETURNED IMPLANTS SHOWS MARKS ON THE TIPS OF THE HUB WHERE THE SET SCREWS CONTACTED. THIS CONTACT POINT IS TOO CLOSE TO THE EDGE OF THE HUB WHERE THERE IS RISK OF THE SET SCREW PUSHING THE IMPLANT APART AFTER HITTING THE ROUNDED CORNER OF THE HUB. IT IS LIKELY THE SECOND SET SCREW DID PUSH THE HUB AND MATING IMPLANT AWAY AND CONTINUED TO DRIVE DOWN TO THE POINT WHERE THE DRIVER WAS NO LONGER ENGAGED. THIS WOULD GIVE THE RESULT OF THE DRIVER CONTINUING TO TURN, BUT THE SET SCREW NOT MOVING. WHAT WAS REPORTED AS "STRIPPED" WAS ACTUALLY ADVANCED TOO FAR DUE TO THE LIMITED COMPRESSION. THE SECOND IMPLANT WAS PLACED MORE ANTERIOR THAN THE FIRST PLACEMENT ATTEMPT WHICH ALLOWED THE IMPLANT TO BE COMPRESSED A BIT MORE DUE TO THE FLARING OUT OF THE LAMINA AS THE SPINOUS PROCESS TRANSITIONS FROM POSTERIOR TO ANTERIOR. IMAGE 1: IMAGE SHOWING THE SET SCREW MARKS ON THE FIRST IMPLANTS ATTEMPT. IMAGE 2: IMAGE SHOWING THE SET SCREW ADVANCED TOO FAR ON ONE OF THE TWO CONSTRUCT IMPLANTS. IMAGE 3: REMEDIAL ACTION MENTIONED IN H2 IN DRAFT FORM, PENDING APPROVAL IN QMS. CONCLUSION: THE CHALLENGING ANATOMY PROHIBITED THE DEVICE FROM BEING ADEQUATELY COMPRESSED AND LOCKED. LOCKING POSITION TO BE ADDED TO THE SURGICAL TECHNIQUE. NO HARM TO PATIENT REPORTED.