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 02-059: FEMALE (YOB: 1983) WITH BMI OF 37 KG/M2 (211LB, 63IN). SHE REPORTED REGULARLY USING NICOTINE; HOWEVER, THE AMOUNT WAS NOT DOCUMENTED. PRIOR TO HER TREATMENT WITH FACET CAGES, THE SUBJECT HAD AN ALIF AT THE L6-S1 LEVEL (B)(6) 2016 TO TREAT LUMBAR INSTABILITY. ON (B)(6) 2018, THEY RECEIVED FACET CAGES AT L5-L6 AND L6-S1 FOR TREATMENT OF DEGENERATIVE INSTABILITY WITH RETROLISTHESIS AND PSEUDARTHROSIS. THE L6-S1 LEVEL WAS TREATED UNILATERALLY ON THE LEFT SIDE. THE ORIGINAL SURGERY PLAN CALLED FOR AN OLIF AT L5-L6; HOWEVER UNFAVORABLE ANATOMY RESULTED IN THAT APPROACH BEING CANCELED. ON (B)(6) 2021 THE SUBJECT RETURNED FOR A POST-OPERATIVE FOLLOW-UP WHERE THEY REPORTED NO RELIEF FROM THE INTERVENTION. THEY SPECIFICALLY MENTIONED RIGHT LOWER LUMBAR AND RADIATING RIGHT LEG PAIN. AT THAT VISIT, IT WAS PROPOSED THAT ADDITIONAL STABILIZATION THROUGH BILATERAL PEDICLE SCREW AND ROD FIXATION FROM L5-S1 AS WELL AS A RIGHT L6-S1 FORAMINOTOMY COULD BE BENEFICIAL. THE SUBJECT RETURNED ON (B)(6) 2018 AND CONFIRMED THAT THEY WOULD LIKE TO PROCEED WITH SURGICAL PLAN DISCUSSED IN AUGUST VISIT. IMAGING COLLECTED AT THIS VISIT CONFIRMED GOOD POSITIONING OF FACET CAGES AT L5-L6 AND L6-S1. THE SUBJECT RETURNED FOR SURGERY ON (B)(6) 2019 AND WAS PERFORMED AS PLANNED WITHOUT COMPLICATIONS. ON THE (B)(6) 2019 CLINIC FOLLOW-UP SHE REPORTED THAT HER BACK PAIN WAS RELIEVED. SHE FURTHER EXPLAINED THAT THE FIRST TWO WEEKS FOLLOWING TREATMENT RESULTED IN SYMPTOM RELIEF, BUT THAT SINCE THEN HAS SUFFERED FROM CONSTANT EXCRUCIATING RIGHT LOWER EXTREMITY PAIN FROM THE BUTTOCKS TO THE CALF. A 1MM CT WAS ORDERED WITH INSTRUCTIONS TO FOLLOW-UP IN THE FUTURE. THE SUBJECT RETURNED (B)(6) 2019 TO REVIEW RESULTS OF CT. THE SCAN REVEALED HALOING AROUND THE RIGHT S1 SCREW. IT WAS RECOMMENDED REMOVAL OF RIGHT PEDICLE SCREWS FROM L5-L6 TO L6-S1 AND FORAMINOTOMY AT L5-L6. THIS WAS PERFORMED ON (B)(6) 2019. THE PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS. AS A RESULT OF THE FORAMINOTOMY, THE FACET CAGE AT THAT LEVEL WAS REMOVED. THE LAST RECORDED FOLLOW-UP WAS NOTED ON (B)(6) 2019 WHERE THE SUBJECT REPORTED HER PREOPERATIVE LEG PAIN HAD RESOLVED. SHE MENTIONED INCISIONAL PAIN AND STAPLE IRRITATION, HOWEVER INSPECTION OF THE INCISION SUGGESTED NO SIGNS OF INFECTION, ERYTHEMA, OR DRAINAGE. SHE WAS INSTRUCTED TO RETURN IN 8 WEEKS FOR RE-EVALUATION AND A LUMBAR X-RAY STUDY. 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.