TXTIHA IBF SYSTEM

Additional Manufacturer Narrative

PER RISK ASSESSMENT THE FOLLOWING MAY APPLY: "TRIAL IMPLANTED" MAY LEAD TO "FAILED FUSION, IMPLANT MIGRATION, PAIN, SURGICAL DELAY, REVISION SURGERY." "INSTRUMENT BREAKAGE/DAMAGE" MAY LEAD TO "CUSTOMER DISSATISFACTION, SURGICAL DELAY" "OCCURRENCE MAY REQUIRE SUBSEQUENT TREATMENT BUT HAS NO LONG TERM LIFE LIMITING CONSEQUENCES." FOR THIS SPECIFIC CASE, THE ONLY EFFECT ON THE PATIENT THUS FAR HAS BEEN SLIGHT SURGICAL DELAY. [IMPLANTING THE TRIAL IMPLANT IS CONSIDERED OFF-LABEL USE THEREFORE THE SURGEON WILL MONITOR FOR ANY ADVERSE EFFECTS.]

Description of Event or Problem

DURING A TLIF PROCEDURE, THE SURGEON IMPACTED A TRIAL IMPLANT INTO THE DISC SPACE FOR SIZING PURPOSES. WHEN ATTEMPTING TO REMOVE THE TRIAL, THE INNER SHAFT OF THE INSERTER BROKE, LEAVING THE TRIAL EMBEDDED IN THE DISC SPACE. THE SURGEON AGAIN ATTEMPTED TO REMOVE THE TRIAL BY OTHER MEANS, BUT WAS UNABLE TO DO SO AND SUBSEQUENTLY DECIDED TO LEAVE IT IMPLANTED.