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): FEMALE (YOB: 1957) WITH BMI OF 46 KG/M2 (251LB, 62IN) WHO REPORTED NO HISTORY OF NICOTINE USE. IN 2003, SHE WAS TREATED WITH A PLIF FOR TREATMENT OF SPONDYLOLISTHESIS AT L4-L5 WHICH INCLUDED THE USE OF BILATERAL PEDICLE SCREWS ACROSS THE SAME SEGMENT. ON (B)(6) 2018, SHE RETURNED FOR AN ALIF WITH SUPPLEMENTAL BILATERAL FACET CAGES AT L5-S1 AGAIN FOR TREATMENT OF SPONDYLOLISTHESIS. SHE REQUIRED FURTHER TREATMENT ON (B)(6) 2019 TO REMOVE A FRACTURED L5 PEDICLE SCREW AND EXTEND FROM L4 TO S1. A YEAR LATER ON (B)(6) 2020, SHE RETURNED AND HAD THE LEFT S1 SCREW REMOVED AFTER IT WAS POSSIBLY LOOSENED AS A RESULT OF A FALL. SHE AGAIN RETURNED ON (B)(6) 2021 AND HAD THE RIGHT L4-L5 AND L5-S1 SCREW AND ROD CONSTRUCT REMOVED. AT DISCHARGE OF THIS LAST PROCEDURE SHE REPORTED IMPROVEMENT FROM HER PRIOR BACK AND LEG PAIN, BUT THAT THERE WAS NEW ONSET PAIN IN THE LOWER LUMBAR REGION MAKING IT DIFFICULT TO STAND. SHE ALSO HAD A SMALL BLISTER NOTED AT THE INCISION SITE DUE TO AN ALLERGIC REACTION TO THE BANDAGE ADHESIVE. THE WOUND EXHIBITED MILD ERYTHEMA AND WAS PROPHYLACTICALLY TREATED WITH ANTIBIOTICS. THE SUBJECT RETURNED ON (B)(6) 2021 REPORTING THAT THERE WAS NO IMPROVEMENT FROM HER PRE-OPERATIVE RADICULAR OR LUMBAR PAIN. THIS WAS POSSIBLY DUE TO FORAMINAL STENOSIS AT THE RIGHT L5-S1 LEVEL. ON (B)(6) 2021, A FORAMINOTOMY WAS PERFORMED AT THE RIGHT L5-S1 WHICH INCLUDED REMOVAL OF THE IMPLANTED FACET CAGE. AT THE TIME OF REMOVAL, THE FACET CAGE WAS "WELL HEALED" IN THE FACET JOINT AND NO COMPLICATIONS WERE NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE FORAMINOTOMY PROCEDURE AND DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2021. THE DELAY IN DISCHARGE WAS DUE TO A SUSPECTED INCISION INFECTION REQUIRING PLACEMENT OF A DRAIN AND WOUND VAC (RESULTS POSITIVE PSEUDOMONAS) AND DIFFICULTY WITH PAIN CONTROL. AT A CLINIC FOLLOW-UP VISIT ON (B)(6) 2021, THE SUBJECT REPORTED RESIDUAL RIGHT LEG AND BACK PAIN. THE INCISION WOUND WAS STILL OPEN AND CLEAN. SUBJECT WAS PRESCRIBED CONTINUED IV ANTIBIOTICS AND REFERRED TO AN INFECTIOUS DISEASE SPECIALIST. THE LAST DOCUMENTED FOLLOW-UP WAS NOTED ON (B)(6) 2022 WHERE THE SUBJECT INFORMED THE CLINIC SHE WAS DIAGNOSED WITH MUSCLE DYSTROPHY CONFIRMED WITH MUSCLE BIOPSY. SHE COMPLAINED OF WORSENING BACK PAIN AND DIFFUSE BILATERAL LOWER EXTREMITY PAIN. THERE WERE NO CURRENT IMAGES AVAILABLE, BUT PRIOR MRI SUGGESTED POSSIBLE DEGENERATIVE CHANGES WITH STENOSIS AT L3-L4. SHE WAS ORDERED A NEW MRI AND REFERRED TO A PAIN MANAGEMENT DOCTOR WITH INSTRUCTIONS TO RETURN ONCE NEW MRI IS ACQUIRED. NO RECORDS BEYOND THIS LAST VISIT WERE AVAILABLE AT TIME OF 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.