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 (B)(6): FEMALE (YOB: 1967) WITH BMI OF 25 KG/M2 (140LB, 62IN) WITH NO DOCUMENTED HISTORY OF NICOTINE USE. ON (B)(6) 2019, THE SUBJECT WAS TREATED WITH AN ALIF AT L5-S1 WITH SUPPLEMENTAL STABILIZATION THROUGH BILATERAL FACET CAGES AT THE SAME LEVEL. INDICATION FOR TREATMENT WAS CENTRAL DISC HERNIATION AND DEGENERATIVE INSTABILITY. THE SUBJECT RETURNED TO THE CLINIC FOR A POST-OPERATIVE FOLLOW-UP ON (B)(6) 2019 WHERE SHE COMPLAINED OF REGULAR CALF CRAMPING WHICH STARTED THREE DAYS EARLIER. PHYSICAL EXAM DISCOVERED A POSITIVE HOMAN'S SIGN. SURGICAL WOUNDS WERE WELL HEALED. SHE WAS ORDERED A VENOUS DOPPLER TO RULE OUT BLOOD CLOTS AND INSTRUCTED TO RETURN FOR FOLLOW-UP X-RAYS. ON (B)(6) 2019, THE SUBJECT RETURNED AGAIN TO THE CLINIC WITH COMPLAINTS OF PROGRESSIVELY WORSENING MUSCLE SPASMS AT THE LOW BACK, BUTTOCKS IN ADDITION TO RIGHT LEG PAIN. THE PRESCRIBED PAIN MEDICATION WAS NOT IMPROVING THESE SYMPTOMS. WHEN REVIEWING X-RAYS, ALL IMPLANTS HAD GOOD POSITIONING. AN MRI SCAN WAS ORDERED TO EVALUATE POTENTIAL DEGENERATION AT THE ADJACENT SEGMENTS. ON SUBJECT'S (B)(6) 2019 FOLLOW-UP, THE SUBJECT REPORTED IMPROVEMENT IN HER PRE-OPERATIVE LOWER BACK PAIN, HOWEVER IS COMPLAINING OF NEW SYMPTOMS OF RIGHT LEG PAIN EXTENDING FROM LOW BACK/BUTTOCK DOWN TO POSTERIOR ASPECT OF LEG TO THE TOES. THE PAIN WAS AT A POINT WHERE SHE HAS CONTEMPLATED GOING TO THE ER SEVERAL TIMES. THE MRI ORDERED AT THE LAST VISIT WAS REVIEWED AND SUGGESTED NORMAL DISCS AT ADJACENT SEGMENTS, BUT POTENTIAL FORAMINAL STENOSIS DUE TO INTERBODY INSTRUMENTATION. THE INSTRUMENT POSITIONING WAS DIFFICULT TO CONFIRM DUE TO METAL ARTIFACTS. A CT WAS ORDERED TO FURTHER EXPLORE DEVICE POSITIONING. ON (B)(6) 2019, THE SUBJECT RETURNED WITH COMPLAINING OF CONTINUED MUSCLE SPASMS IN RIGHT BUTTOCK AND BACK. THE PAIN HAS PREVENTED HER FROM SLEEPING OR GETTING THOUGH REGULAR DAILY ACTIVITIES. THE CT SHOWED RIGHT SIDED STENOSIS AT L5-S1 POSSIBLY DUE TO RETAINED DISC FRAGMENT OR DISC HERNIATION. THE INTERBODY DEVICE AND SCREWS AS WELL AS THE FACET CAGES WERE IN GOOD POSITION AND EMBEDDED WITHIN THE BONE. THE SURGEON PRESENTED A SURGICAL PLAN THAT INCLUDED A RIGHT L5-S1 FORAMINOTOMY TO RELIEVE THE STENOSIS AS WELL AS EXPLORATION FOR ANY POSSIBLE RETAINED DISC FRAGMENTS FROM THE ORIGINAL INTERBODY FUSION PROCEDURE. THE PLANNED PROCEDURE WAS PERFORMED WITHOUT COMPLICATION ON (B)(6) 2019. THE FORAMINOTOMY NECESSITATED THE REMOVAL OF THE RIGHT FACET CAGE TO ACHIEVE DESIRED NERVE ROOT DECOMPRESSION. AT TIME OF REMOVAL, THE CAGE WAS FOUND TO BE WELL WITHIN THE FACET JOINT. THE SUBJECT WAS SEEN IN THE CLINIC ON (B)(6) 2019 WHERE THEY REPORTED INITIAL RELIEF OF THEIR BACK PAIN, BUT THAT THERE WAS A SUDDEN RETURN OF SYMPTOMS TO PRE-OPERATIVE LEVELS A DAY PRIOR TO THE VISIT, LEADING HER TO PRESENT TO THE EMERGENCY DEPARTMENT. AN UPDATED MRI WAS ORDERED AND SHE WAS INSTRUCTED TO RETURN ONCE IT WAS COMPLETED. THE SUBJECT RETURNED ON (B)(6) 2019 WITH SAME PAIN SYMPTOMS IN ADDITION TO NEW NUMBNESS IN PROXIMAL LEFT THIGH AND SWELLING IN BACK. THE POSTERIOR WOUND APPEARED CLEAN AND FREE OF INFECTION. A SYRINGE WAS USED TO DRAIN THE SWELLING AND 10CC OF SEROSANGUINOUS FLUID WAS REMOVED AND SENT FOR CULTURE. THIS PROVIDED SOME RELIEF TO THE SUBJECT. THE SUBJECT WAS SEEN AGAIN ON (B)(6) 2019 WITH NO CHANGE IN SYMPTOMS. THE SWELLING IN THE BACK WAS AGAIN DRAINED WITH 9CC COLLECTED, PROVIDING RELIEF. RESULTS OF CULTURES WERE NOT YET AVAILABLE FROM INITIAL DRAINAGE. THE MRI WAS REVIEWED WHICH CONFIRMED THE SUPERFICIAL FLUID DRAINED AS WELL AS A DEEPER FLUID COLLECTION POSSIBLY COMPRESSING RIGHT NERVE ROOT. IT WAS PRESENTED TO THE SUBJECT THAT A CT GUIDED DRAINING OF THE DEEP FLUID COULD PROVIDE RELIEF, HOWEVER THEY CHOSE TO WAIT TO SEE IF IT WOULD RE-ABSORB. THE SUBJECT WAS ASKED TO RETURN IN 4-6 WEEKS TO CHECK ON STATUS OF SWELLING. THE SUBJECT RETURNED ON (B)(6) 2019 WITH COMPLAINTS OF IMPROVEMENTS IN LOWER BACK PAIN, BUT PERSISTENT LEFT LEG PAIN AND FOCAL PAIN AT THE TIP OF THE BUTT CRACK. THESE SYMPTOMS WERE PRESENT PRIOR TO ANY SURGICAL TREATMENT, BUT HAD BECOME MORE OF A PROBLEM LATELY. THE MOST RECENT X-RAYS OF THAT REGION INDICATED A MINIMAL POSTERIOR STEP-OFF POSSIBLY DUE TO AN OLD INJURY. AT THIS VISIT AN INJECTION AT THE LOCATION OF THE PAIN TO TREAT THE COCCYDYNIA. A COCCYGECTOMY WAS PRESENTED TO THE SUBJECT AND THEY RESPONDED THAT THEY WOULD LIKE THE PROCEDURE PERFORMED. THE SUBJECT ALSO REQUESTED THAT THE CT GUIDED DRAINING PRESENTED AT THE LAST VISIT BE PERFORMED, HOWEVER THE SURGEON REQUESTED A NEW MRI BEFORE PROCEEDING. THE COCCYGECTOMY WAS PERFORMED ON (B)(6) 2019. AT A FOLLOW-UP ON (B)(6) 2020, THE SUBJECT REPORTED IMPROVEMENTS IN ALL COMPLAINTS. THERE WAS ONGOING DRAINAGE FROM THE COCCYGECTOMY SITE, BUT THAT THERE WAS LITTLE TO BE DONE ACCORDING TO THE WOUND CENTER. THE WOUND DID NOT APPEAR INFECTED. A PELVIC CT AND MRI WERE ORDERED. NO FURTHER CLINIC NOTES WERE AVAILABLE AT TIME OF WRITING THIS REPORT. 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.