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: LUMBAR STUDY SUBJECT 02-098: FEMALE WITH BMI OF 47 KG/M2 (300LB, 67IN) WHO IS RECORDED AS SMOKING BETWEEN 1.5 AND 2.0 PACKS OF CIGARETTES PER DAY. THEY WERE FIRST TREATED WITH AN ALIF AT L5-S1 INCLUDING LEFT PEDICLE SCREWS AND RODS ACROSS THAT SEGMENT FOR THE TREATMENT OF CENTRAL DISC HERNIATION, RETROLISTHESIS, AND LUMBAR INSTABILITY. ON (B)(6) 2018 THEY RECEIVED ADDITIONAL FIXATION THROUGH IMPLANTATION OF RIGHT PEDICLE SCREWS AND RODS ACROSS L5-S1. A PSEUDARTHROSIS AT THE SAME L5-S1 WAS TREATED WITH SUPPLEMENTAL STABILIZATION THROUGH THE USE OF FACET CAGES IMPLANTED BILATERALLY OVER TWO SEPARATE PROCEDURES. THE RIGHT CAGE WAS FIRST DELIVERED ON (B)(6) 2019 FOLLOWED BY THE LEFT CAGE ON (B)(6) 2019. THE PEDICLE SCREW AND ROD CONSTRUCTS WERE REMOVED DURING THE SECOND PROCEDURE. ON (B)(6) 2019, THE SUBJECT RETURNED FOR A FOLLOW-UP COMPLAINING OF NEW ONSET RIGHT LUMBAR RADICULOPATHY IN ADDITION TO PAIN FROM THE RIGHT BUTTOCK DOWN TO THE KNEE. THE X-RAYS AT THAT VISIT SUGGESTED GOOD POSITIONING OF THE INTERBODY CAGE AND BOTH FACET CAGES, HOWEVER CT WAS ORDERED TO CONFIRM THE PLACEMENT. HER PREOPERATIVE LEFT LEG PAIN WAS REPORTED TO HAVE IMPROVED FOLLOWING THE PROCEDURE. THE CT STUDY WAS REVIEWED ON A (B)(6) 2019 VISIT WHERE IT WAS DISCOVERED THE RIGHT FACET IMPLANT AT L5-S1 WAS PLACED MEDIAL AND POTENTIALLY IRRITATING THE NERVE ROOT. A RIGHT FORAMINOTOMY AT L5-S1 WAS DISCUSSED WHICH INCLUDED REMOVAL OF THE CAGE AT THAT LOCATION. THE PROCEDURE WAS SUCCESSFULLY PERFORMED ON (B)(6) 2019 WITH NO DOCUMENTED COMPLICATIONS. THE SUBJECT RETURNED FOR A POST-OPERATIVE FOLLOW-UP ON (B)(6) 2019. SHE COMPLAINED OF RESIDUAL PAIN AT THE SURGICAL SITE AND WAS CONCERNED ABOUT DRAINAGE FROM THE SURGICAL INCISION. THE WOUND WAS INSPECTED AND DID NOT APPEAR INFECTED. THE SUBJECT REPORTED NO INSTANCES OF FEVER OR CHILLS. THEY WERE PRESCRIBED ANTIBIOTICS, BUT NO NARCOTICS. INSTEAD, THE PHARMACIST REQUESTED THAT THE SUBJECT DISCUSS THEIR PAIN MANAGEMENT PLAN WITH THEIR PRIMARY CARE DOCTOR. THE SUBJECT RETURNED FOR ANOTHER FOLLOW-UP ON (B)(6) 2019 STATING THAT SHE FEELS NO RELIEF FROM HER PAST PROCEDURE WITH PAIN RETURNING FROM HER RIGHT BACK DOWN THROUGH HER KNEE. HER INCISION WAS HEALED AT THIS TIME WITH MILD TENDERNESS TO PALPATION. THE SUBJECT WAS ASKED TO FOLLOW-UP IN 4-6 WEEKS. THE SUBJECT RETURNED ON (B)(6) 2019 COMPLAINING THAT THE PAIN IS DIFFICULT TO CONTROL THROUGH PRESCRIBED MEDICATIONS WITH ONLY MINIMAL RELIEF PROVIDED BY SUBOXONE. X-RAYS SUGGEST GOOD POSITIONING OF ALL INSTRUMENTATION, BUT AN MRI WAS ORDERED TO CONFIRM INTEGRITY OF THE DISCS. THE RESULTS OF THE MRI WERE REVIEWED ON (B)(6) 2020. AT THIS VISIT THE SUBJECT STILL HAD SEVERE RIGHT LEG PAIN WITH NEW ONSET PAIN ON THE LEFT LEG. THE MRI SUGGESTS A MODERATE HERNIATION AT L4-L5. CT SCANS SHOW WELL-HEALED FUSION AT L5-S1. THE PAIN AT THIS POINT HAS COMPLETELY DISABLED HER AND HER DAILY LIVING IS COMPLETELY COMPROMISED. A LEFT SIDED OLIF AT THE L4-L5 LEVEL WITH ANTEROLATERAL PLATE IN ADDITION TO POSTEROLATERAL FUSION WITH PEDICLE SCREW AND ROD FIXATION AT THE L4-L5 LEVELS WAS PROPOSED. AT THE TIME OF THIS REPORT, IT IS UNKNOWN WHETHER THE SUBJECT PROCEEDED WITH THE SURGICAL PLAN PROPOSED AT THIS VISIT. 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.