PRONEX CERVICAL TRACTION

Additional Manufacturer Narrative

RETURNED PRONEX CERVICAL TRACTION DEVICE WAS RECEIVED ON (B)(4) 2010 AND WAS EVALUATED. THE RETURNED DEVICE MET ALL APPLICABLE PERFORMANCE SPECS AND NO PROBLEMS WERE FOUND. ADDITIONAL INFO LATER PROVIDED DETERMINED THAT THE ACCESSORY FLEXION WEDGE WAS THE PART THAT THE PT HAD DESCRIBED AS SLIPPING OFF AND FALLING BEHIND HIS BED. THE FLEXION WEDGE IS NOT POSITIVELY AFFIXED TO THE PRONEX HEADPIECE AND IS NOT INTENDED TO BE. THE HEADPIECE IS JUST TO REST ON THE FLEXION WEDGE. IT IS CONCEIVABLE THAT THE FLEXION WEDGE COULD SLIP OUT FROM UNDER THE HEADPIECE BUT A RETURNED PRODUCT EXAMINATION WOULD FAIL TO DETECT SUCH A CIRCUMSTANCE. MDR FILED - (B)(4) 2010.

Description of Event or Problem

PT REPORTED EXACERBATION OF NECK PAIN DURING A CERVICAL TRACTION TREATMENT WHEN AN ACCESSORY FLEXION WEDGE SLIPPED OUT FROM UNDER THE CERVICAL TRACTION HEADPIECE. PT SAID HE WAS IN PAIN EVER SINCE. PT DESCRIBED THAT THE ACCESSORY FLEXION WEDGE SLIPPED OUT FROM UNDER THE PRONEX CERVICAL TRACTION ASSEMBLY WITH THE PT IN BED. THE FLEXION WEDGE OR "PAD" AS THE PT DESCRIBED IT FELL BEHIND THE PT'S BED. PT SPOKE WITH PHYSICIAN AND WAS TOLD TO STOP USING THE DEVICE. PT TALKING WITH PHYSICIAN ABOUT GETTING SHOTS OR SPINAL BLOCK TO ADDRESS THE PAIN.