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): MALE (YOB: 1981) WITH BMI OF 25 KG/M2 (190LB, 72IN). THEY HAD A HISTORY OF NICOTINE USE, BUT WAS NOT SMOKING AT TIME OF SURGERY WITH FACET CAGES. IN 2011, SUBJECT WAS IN A MVA RESULTING IN LUMBAR RADICULOPATHY, INSTABILITY, AND A HERNIATED DISC. THEY RECEIVED AN OLIF AT L4-L5 WITH PEDICLE SCREWS AND RODS BILATERALLY FROM L4-L5. THEY RETURNED A YEAR LATER WHERE THEY COMPLAINED OF PAIN FROM THE PEDICLE SCREWS INCLUDING LOWER BACK AND LEG PAIN. ON (B)(6) 2018, THE PEDICLE SCREW AND ROD CONSTRUCTS WERE REMOVED AND REPLACED WITH FACET CAGES. AT A (B)(6) 2019 FOLLOW-UP, THE SUBJECT COMPLAINED OF PERSISTENT BACK AND LEG PAIN SIMILAR TO LEVELS BEFORE THE REVISION. X-RAYS AT THAT TIME SHOWED GOOD IMPLANT POSITIONING (BOTH INTERBODY AND FACET CAGES) BUT ALSO COMMENTED OF LATERAL COLLAPSE ON THE RIGHT SIDE L3-L4. AT A (B)(6) 2019 FOLLOW-UP, THERE WAS NO CHANGE IN SYMPTOMS AND AN MRI AND FINE SLICE CT STUDY WAS ORDERED. THE SUBJECT RETURNED ON (B)(6) 2019 WHERE THEY REPORTED NO IMPROVEMENT IN BACK/LEG PAIN. THE MRI SHOWED INTACT INTERVERTEBRAL DISCS. CT IDENTIFIED FORAMINAL STENOSIS AT RIGHT L4-L5. THE CAGE IN THAT FACET WAS SLIGHTLY LATERAL, BUT STENOSIS WAS MORE LIKELY RESULT OF FACET ARTHROPATHY. AT THIS VISIT A DECOMPRESSION OF THE L5 NERVE ROOT VIA A FORAMINOTOMY AT L4-L5 WAS DISCUSSED. ON (B)(6) 2019, THE FORAMINOTOMY WAS SUCCESSFULLY PERFORMED AT THE RIGHT L4-L5. THE OPERATIVE NOTES DETAILED THAT PRIOR TO REMOVAL, THE FACET CAGE WAS WELL FUSED AND IMBEDDED IN THE BONE. NO COMPLICATIONS WERE DOCUMENTED DURING THE PROCEDURE. THE SUBJECT RETURNED (B)(6) 2019 FOR ROUTINE FOLLOW-UP WHERE THEY COMPLAINED OF RESIDUAL RIGHT LEG PAIN AND SOME SURGICAL DISCOMFORT. THE INCISION WAS WELL HEALED AND SHOWED NO SIGN OF INFECTION. THE PATIENT RETURNED FOR A SUBSEQUENT FOLLOW-UP (B)(6) 2019. THEY DESCRIBED THAT THE FORAMINOTOMY ON (B)(6) 2019 BROUGHT INITIAL RELIEF OF BACK AND LEG PAIN, BUT THAT BOTH RETURNED IN ADDITION TO NEW ONSET LEFT LEG PAIN. NEW MRI AND CT IMAGING WERE ORDERED AT THIS TIME. THE SUBJECT RETURNED FOR ADDITIONAL FOLLOW-UP ON (B)(6) 2020 TO REVIEW IMAGING WHICH BOTH SUGGESTED DECOMPRESSION AND FUSION FROM L4-S1 WITH NO EVIDENCE OF ADJACENT SEGMENT DISEASE. SUBJECT WAS STILL COMPLAINING OF RADIATING PAIN INTO BOTH LEGS AT THIS TIME AND THEY WERE TOLD TO RETURN IN 6 MONTHS FOR ADDITIONAL X-RAYS. ON (B)(6) 2020 SUBJECT RETURNED WITH PERSISTENT LEG PAIN. SCANS SUGGESTED SOLID FUSION AT L5-S1, BUT POSSIBLE PSEUDARTHROSIS AT L4-L5 AS EVIDENCE OF CLEFTS AROUND INTERVERTEBRAL CAGE AND INCOMPLETE FACET FUSION ON LEFT L4-L5. A SURGICAL PLAN INVOLVING IMPLANTING A RIGHT LATERAL INTERBODY PLATE AT L4-L5 WAS DISCUSSED AT THIS TIME. THE PROCEDURE WAS PERFORMED ON (B)(6) 2020 WITHOUT COMPLICATION. THE LAST DOCUMENTED FOLLOW-UP ON THIS ISSUE WAS ON (B)(6) 2020 WHERE THE SUBJECT DESCRIBED IMPROVED STABILITY, BUT COMPLAINED OF RIGHT SIDED PROXIMAL THIGH NUMBNESS AND TINGLING WITH SECONDARY LEG PAIN. OVERALL THE SUBJECT FEELS THAT EARLY ON THE MOST RECENT SURGERY WAS A SUCCESS. 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.