Description of Event or Problem · 0
ON (B)(6) 2024 WE RECEIVED A COMPLAINT OF A SCREW BREAKING DURING REMOVAL SURGERY. ON (B)(6) 2024, A HARDWARE REMOVAL SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAINFUL HARDWARE LOCATED AT L5-S1 THAT WAS IMPLANTED (B)(6) 2023. MRI IMPRESSION DATED (B)(6) 2024 CONFIRMED HARDWARE PRESENT AT L5/S1 AND GRAFT FUSION OF THE DISC SPACE WAS PRESENT AT L5/S1. THE PAIN WAS CONFIRMED VIA A HARDWARE BLOCK WITH A POSITIVE RESPONSE AT THE L5/S1 LEVEL. THERE WAS NO MENTION OF A FRACTURED OR BROKEN SCREW IN THE MRI IMPRESSION REPORT. LOCKING CAPS, RODS AND BOTH PEDICLE SCREWS WERE SUCCESSFULLY REMOVED FROM THE LEFT SIDE OF L5-S1. LOCKING CAPS, RODS AND THE FIRST PEDICLE SCREW ON THE RIGHT L5 WAS REMOVED ENTIRELY. DURING REMOVAL OF THE RIGHT S1 PEDICLE SCREW, THE SCREW FRACTURED AT THE INTERSECTION OF THE HEAD AND THE SHANK OF THE SCREW. THE HEAD WAS REMOVED FROM THE PATIENT BUT THE LOWER SHANK STILL REMAINED IMPLANTED. THE DECISION WAS MADE BY THE SURGEON THAT REMOVING THE REMAINING PORTION OF THE SCREW WOULD REQUIRE EXTENSIVE BONY DECONSTRUCTION TO REMOVE ENOUGH BONE TO BE ABLE TO GET ENOUGH HOLD OF THE REMAINING SCREW SO IT WAS LEFT EMBEDDED WITHIN THE RIGHT S1. THE REMAINING PORTION POSED NO RISK TO THE PATIENTS RECOVERY, FUTURE WELLBEING OR RISK TO THE INTERBODY IMPLANT PREVIOUSLY IMPLANTED AT L5-S1. FLOUROSCOPY IMAGES WERE TAKEN AND CONFIRMED THERE HAD BEEN NO METAL DEBRIS FROM THE FRACTURED SCREWS. THE PROCEDURE CONTINUED WITHOUT ANY FURTHER COMPLICATIONS DURING OR AFTER THE SURGERY. WE ARE STAYING IN CONTACT WITH THE SURGEON IN REGARD TO THIS PATIENT AND AS OF SEPTEMBER 2025 WE HAVE NOT HEARD OF ANY ADVERSE EVENTS OR COMPLICATIONS DUE TO THE REMAINING PORTION OF THE SCREW BEING LEFT IN THE PATIENT. THE FDA OBSERVATION REPORT DATED 8/29/25 SUGGESTED THAT THE DEVICE HAD MALFUNCTIONED AND WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THE MRI IMPRESSION DATED (B)(6) 2024 STATED THAT L5/S1 WAS FUSED AT THE DISC SPACE MEANING THAT THE FUSION SURGERY WAS SUCCESSFUL AND THE SCREW CONSTRUCT PERFORMED AS WAS EXPECTED. THE SCREW DID NOT FAIL OR CREATE A FAILED FUSION WHICH COULD HAVE REQUIRED A REVISION SURGERY. THE PATIENT DID NOT NEED REVISION SURGERY FOR A LOW TOP NON-CANNULATED SCREW AS WAS REPORTED ERRONEOUSLY IN THE OBSERVATION. THE PATIENT ONLY HAD A HARDWARE REMOVAL SURGERY DUE TO HARDWARE PAIN AND THE SCREW BREAKAGE OCCURRED AT THE TIME OF REMOVAL.