inforMED
MalfunctionIQK

VISTA CTO

Received May 2, 2023 · Event occurred Mar 2, 2023

Report 16852689 · MDR key 16852689

Device

Generic name

Orthosis, Cervical

Model number

984510

Catalog number

984510

Product problems

  • Structural Problem

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

POSTERIOR HEAD WOUND WAS FOUND ABOVE CTO-BRACE ON OCCIPUT (BACK OF HEAD). WHEN THEY COULD START SITTING HIM UP WITH THE CTO DEVICE, THEY DID. HOWEVER, THE CTO DEVICE HAS A WAIST STRAP AND IF THE PATIENT HAS A LARGER ABDOMEN IT WILL PUSH UP ON THE WHOLE DEVICE INCLUDING ON THE MANDIBLE AND BACK OF THE HEAD. THE PADDING ON THE COLLAR IS NOT PROTECTIVE ENOUGH AND THE HARD PIECE CAN SNEAK OVER THE PADDING. HANGER CLINIC DID COME BACK TO ADJUST THE DEVICE AND PATIENT KEPT TRYING TO TAKE THE BRACE OFF BECAUSE IT WAS SO UNCOMFORTABLE. PHOTOS AVAILABLE.