Description of Event or Problem · 0
THIS EVENT WAS DISCOVERED WHEN PMT INITIATED A REVIEW OF A REGISTRY THAT COLLECTED DATA REGARDING THE CLINICAL PERFORMANCE OF PMT DEVICES IN REAL-WORLD USE. IN THIS CASE, THE EVENT WAS NOT REPORTED AS A COMPLAINT BY THE CUSTOMER AND THERE WAS NO DEVICE DEFECT OR MALFUNCTION RELATED TO THE DEVICE AT THE TIME OF SURGERY. PER PATIENT HISTORY NOTES: SUBJECT (B)(6): FEMALE (YOB: 1956) WITH BMI OF 34 KG/M2 (170LB, 59IN) AND DOCUMENTED AS BEING A REGULAR SMOKER. BY THE TIME OF THEIR TREATMENT WITH FACET CAGES, THEY HAD AN EXTENSIVE HISTORY OF LUMBAR PROCEDURES INCLUDING AN IDET PROCEDURE AT L5-S1 ((B)(6) 2002), AN ALIF AT L5-S1 ((B)(6) 2004), PEDICLE SCREW FIXATION AT L5-S1 ((B)(6) 2004), REVISION OF PEDICLE SCREW FIXATION AT L5-S1 ((B)(6) 2004), AND A LLIF AT L1-L2 AND L2-L3 ((B)(6) 2017). ON (B)(6) 2018, THE SUBJECT HAD PEDICLE SCREWS AND RODS REMOVED FROM L1-L2 AND L2-L3 AND FACET CAGES PLACED BILATERALLY AT L3-L4 AND L4-L5 FOR THE TREATMENT OF LUMBAR RADICULOPATHY, FACET ARTHROPATHY, AND FORAMINAL STENOSIS AND PAIN FROM PEDICLE SCREWS. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2018. THE SUBJECT WAS SEEN FOR A FOLLOW-UP ON (B)(6) 2018 WITH COMPLAINTS OF LEFT LEG PAIN FROM BUTTOCK TO LATERAL LEFT CALF. AT THIS VISIT A CT WAS ORDERED TO EVALUATE HARDWARE POSITIONING. ON (B)(6) 2019 THE SUBJECT RETURNED FOR REVIEW OF CT. THE FACET CAGES BILATERALLY AT L4-L5 WERE IN GOOD POSITION AS WAS THE RIGHT CAGE AT L3-L4. THE LEFT CAGE AT L3-L4 APPEARED TO BE PROJECTING MEDIALLY INTO THE NEURAL FORAMEN POSSIBLY IRRITATING THE LEFT L3 AND L4 NERVE ROOTS. AT THIS VISIT SHE CONTINUED TO REPORT LEFT LEG PAIN. THE ONSET OF THIS PAIN WAS A MONTH FOLLOWING INTERVENTION MAKING IT POSSIBLE THAT THE CAGE HAS MIGRATED. A SURGICAL PLAN WAS DISCUSSED INVOLVING A FORAMINOTOMY AT LEFT L3-L4 INCLUDING THE REMOVAL OF ONE FACET CAGE. THE SUBJECT WAS NEXT SEEN ON (B)(6) 2019 WHERE SHE COMPLAINED OF SEVERE BACK PAIN ON LEFT SIDE AND DIFFICULTY STANDING FOLLOWING A FALL ((B)(6) 2019). NO IMAGING WAS AVAILABLE AT THAT TIME. THE L3-L4 RIGHT FORAMINOTOMY PROCEEDED AS PLANNED ON (B)(6) 2019. ADEQUATE DECOMPRESSION OF THE L3 AND L4 NERVE ROOTS WAS ACHIEVED AND THE LEFT (??) CAGE WAS REMOVED WITHOUT ANY COMPLICATIONS. THE SUBJECT RETURNED ON (B)(6) 2019 FOR A ROUTINE FOLLOW-UP WHERE THEY REPORTED IMPROVEMENT IN HER LEFT LEG PAIN WITH SOME RESIDUAL BACK AND RIGHT LEG PAIN. SINCE THE FORAMINOTOMY AND REMOVAL, THE SUBJECT REQUIRED A SUBSEQUENT OLIF AT L3-L4 AND L4-L5 FOR TREATMENT OF ADJACENT SEGMENT DISEASE, DISC HERNIATION, AND INSTABILITY. ON (B)(6) 2021 AND (B)(6) 2021, THE SUBJECT HAD A THORACIC LAMINECTOMY AND PLACEMENT OF TRIAL EPIDURAL STIMULATOR AT T9-T10 FOR TREATMENT OF RADICULOPATHY AND LOW BACK PAIN. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING HARM OR INJURY TO THE PATIENT, NO INFORMATION ABOUT A DELAY AND NO ADVERSE EVENT WAS REPORTED BY THE SURGEON RELATED TO THE FACET CAGE. DUE DILIGENCE IS COMPLETE.