SAUNDERS CERVICAL TRACTION
Received Aug 10, 2010 · Event occurred Jul 6, 2010
Report 1022819-2010-00012 · MDR key 1812319
Device
Generic name
Cervical Traction Clinical
Manufacturer
Chattanooga GroupModel number
7040Catalog number
7040
Product problems
- Improper or Incorrect Procedure or Method
- Malposition of Device
Patient
Not reported
- Hearing Impairment
- Nerve Damage
- Joint Dislocation
- Numbness
Narrative
Description of Event or Problem
ON (B)(6) 2010, PATIENT REPORTED THAT SHE HAD A HERNIATED DISK AND WENT TO A REHABILITATION CLINIC AND WAS TREATED WITH A SAUNDERS CERVICAL. THE TWO BARS WERE ON HER JAW, NOT NECK, AND IT AFFECTED HER JAW. SHE WAS IN THE DEVICE FOR 7 MINUTES AND SHE STOPPED IT. AFTER THE TREATMENT WAS DISCONTINUED, SHE SAYS THAT THE SIDE OF HER JAW IS NOW OVERLAPPED ON THE RIGHT SIDE, HER BITE IS TERRIBLE AND HER HEARING IS DIMINISHED. IN AN EMAIL ON (B)(6) 2010, THE PATIENT ALSO STATED THAT SHE HAS BEEN DIAGNOSED WITH "RIGHT SIDE JAW DISLOCATION AND A CLOSED LOCK MY OPENING IS AT 7MM..., BUCCAL TRIGEMINAL NERVE DAMAGE POSSIBLY MORE NERVES DUE TO THE EXTENT OF THE NUMBNESS IN THE RIGHT SIDE OF FACE AND HEAD."