inforMED
MalfunctionLOF

EXOGEN ULTRASOUND BONE HEALING SYSTEM

Received Feb 8, 2023 · Event occurred Aug 24, 2022

Report MW5114799 · MDR key 16336748

Device

Generic name

Stimulator, Bone Growth, Non-invasive

Manufacturer

Bioventus Llc.

Product problems

  • Patient Device Interaction Problem

Patient

54 YR · Male

  • Nonunion/Delayed-union Bone Fracture
  • Nonunion/Delayed-union Bone Fracture

Narrative

Description of Event or Problem

THE AUDI L. MURPHY V.A. NEUROSURGERY CLINIC ORDERED ME A CERVICAL SPINE BONE GROWTH STIMULATOR BECAUSE MY SURGEON IDENTIFIED ME AS A HIGH RISK PATIENT FOR NONUNION. THE PROSTHETIC DEPARTMENT ORDERED THIS INSTEAD, THE USERS MANUEL ACTUALLY SAYS NOT TO USE ON THE SPINE. I NOTIFIED NEUROSURGERY AND PROSTHETIC OF THE ERROR. I ALSO CONTACTED EXOGEN TO ADDRESS MY CONCERN. MY DOCTOR, TWO PHYSICIAN ASSISTANTS IN NEUROSURGERY, THE PROSTHETIC DEPARTMENT AND THE REPRESENTATIVE FOR EXOGEN ALL TOLD ME TO DISREGARD THE WARNINGS AND TO USE IT ANYWAY. WHEN I ASKED THE EXOGEN REP IF HE COULD EXPLAIN WHY IT SAYS NOT TO USE IT ON THE SPINE, HE SAID HE DID NOT KNOW, I ASKED HIM IF HE COULD GUARANTEE MY SAFETY, HE SAID NO, THEN HE SAID JUST USE IT ANYWAY IT IS SAFE. IT HAS BEEN 5 GOING ON 6 MONTHS NOW, AND THE V.A. HAS NOT DONE ANYTHING TO FIX THIS ISSUE. I AM KNOW BEING TOLD BY A PHYSICIAN'S ASSISTANT THAT THEY DON'T THINK I NEED TO USE A BONE GROWTH STIMULATOR , SOUNDS LIKE SOMEONE IS LYING OR I HAVE BEEN MISSED DIAGNOSED BY MY SURGEON AND OR THE PHYSICIAN'S ASSISTANT . MY HEALTH CARE TEAM HAS FAILED ME AS A PATIENT WITH COMPLETE INDIFFERENCE. THIS DEVICE MAY HAVE DAMAGED MY SPINE. THIS IS GORSE NEGLIGENCE ON THE PART OF EXOGEN, THE NEUROSURGERY DEPARTMENT, PROSTHETIC DEPARTMENT AND THE ENTIRE V.A. HEALTHCARE SYSTEM . THE EXOGEN BONE GROWTH HEALING SYSTEM IS DANGEROUS IN MY OPINION. THE AUDI L. MURPHY V.A. HOSPITAL NEUROSURGERY DEPARTMENT HAS DONE NOTHING TO ADDRESS MY CONCERNS OF POSSIBLE INJURY FROM THIS DEVICE, THEY HAVE NOT EVEN ORDERED ME THE CORRECT DEVICE IT HAS BEEN FIVE MONTHS GOING ON 6 NOW. THE NEUROSURGERY DEPARTMENT HASN'T EVEN GIVE ME AN EXAM TO MAKE SURE I AM NOT INJURED. ON (B)(6) 2022 I WAS TOLD THAT NEUROSURGERY WOULD NOT EVEN BE SEEING ME ANY MORE AFTER THAT APPOINTMENT, BASICALLY DISCHARGING ME THREE MONTHS IN TO MY ONE YEAR TREATMENT PLANE. THE SURGEON AND DOCTOR WHO ORDERED THE DEVICE HAVE BOTH QUIT WORKING AT OR FOR AUDI L. MURPHY V.A. HOSPITAL AT THE END OF DECEMBER AS WELL. I HAVE BEEN GIVEN AN APPOINTMENT FOR (B)(6) 2023 TO SEE A PHYSICIAN'S ASSISTANT BECAUSE SHE WANTS TO LOOK AT THE DEVICE, NOT AS A FOLLOWUP NOT TO EXAMINE ME OR RUN ANY TESTS.