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 02-128: MALE (YOB: 1979) WITH BMI OF 23 KG/M2 (153LB, 68IN) WHO REGULARLY CONSUMES NICOTINE, BUT HAS BEEN REDUCING USE OVER TIME. THEY RECEIVED TREATMENT ON (B)(6) 2019 FOR A HERNIATED DISC, LUMBAR INSTABILITY, RADICULOPATHY AND RETROLISTHESIS AT L5-S1. THE PROCEDURE INVOLVED AN ALIF SUPPLEMENTED WITH BILATERAL FACET CAGES. THE SUBJECT RETURNED FOR A POST-OPERATIVE FOLLOW-UP ON (B)(6) 2019. THEY REPORTED IMPROVEMENT IN SYMPTOMS DURING THE FIRST 2-3 WEEKS, BUT SINCE HAVE EXPERIENCED INCREASED BACK PAIN AND BILATERAL BUTTOCK AND LEG PAIN TO A POINT ALMOST AS EXTREME AS BEFORE SURGERY. A CT SCAN WAS ORDERED AND THE SUBJECT WAS INSTRUCTED TO RETURN ONCE COMPLETED. THEY RETURNED ON (B)(6) 2020 AND DESCRIBED SYMPTOMS AS NOT IMPROVING, WITH THE LEFT SIDE BEING WORSE THAN THE RIGHT, BUT STILL PRESENT BILATERALLY. THE CT SHOWED GOOD POSITIONING OF THE INTERBODY CAGE AND FACET CAGES. FORAMINAL STENOSIS WAS NOTED ON THE LEFT SIDE SECONDARY TO FACET JOINT HYPERTROPHY AS WELL AS BILATERAL SPONDYLOLYSIS AT L5. A SURGICAL PLAN WAS PRESENTED CONSISTING OF PLACING BILATERAL PEDICLE SCREWS AND RODS AT L5-S1 AS WELL AS FORAMINOTOMY AT THE LEFT SIDE. THE LEFT FORAMINOTOMY REQUIRED REMOVAL OF THE FACET CAGE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2020 AND CONSISTED OF THE PLANNED FORAMINOTOMY AT LEFT L5-S1 ACHIEVING GOOD DECOMPRESSION AND PLACEMENT OF PEDICLE SCREW AND RODS. THE ORIGINAL PLAN WAS TO PLACE PEDICLE SCREWS AND RODS BI-LATERALLY, HOWEVER THESE WERE ONLY PLACED ON THE LEFT SIDE. THE SCREWS AND RODS WERE NOT PLACED ON THE RIGHT DUE TO CONCERN OF THE FACET CAGE OBSTRUCTING PEDICLE ACCESS. THE JOINT WAS ALSO STABLE AND THE FACET CAGE WAS PLACED IN A GOOD POSITION. THERE WERE NO COMPLICATIONS NOTED DURING THE PROCEDURE. THE SUBJECT RETURNED FOR A POST-OPERATIVE FOLLOW-UP ON (B)(6) 2020 AND REPORTED IMPROVEMENTS IN THE LEFT LEG PAIN WITH ONLY MILD SURGICAL PAIN WHICH IS CONTROLLED WITH MEDICATION. THE SUBJECT RETURNED AGAIN ON (B)(6) 2020 WHERE THE SUBJECT REPORTED CONTINUED IMPROVEMENT IN SYMPTOMS WITH ONLY MILD RESIDUAL PAIN IN BACK AND LEGS. THEY REPORT ABILITY TO INCREASE DAILY ACTIVITY AND ARE GETTING QUALITY SLEEP. AT THE TIME OF THIS REPORT, THERE WERE NO ADDITIONAL VISITS DOCUMENTED RELATED TO THE SUBJECT'S COMPLAINTS. 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.