UNK V. MUELLER

Additional Manufacturer Narrative

(B)(4), ADDITIONAL INFORMATION (B)(4) 2013: IT WAS REPORTED BY THE FACILITY THAT THIS REPORT SHOULD NOT BE FOR A V MUELLER PRODUCT AS INITIALLY REPORTED. THE REPORTER AT THE FACILITY WAS TOLD INITIALLY THAT THE HOOK THAT BROKE WAS A V. MUELLER RHOTON HOOKS. AFTER THE REPORTS WERE SUBMITTED, THIS WAS FOUND NOT TO BE TRUE.

Description of Event or Problem

BROKEN THIS REPORT CAME TO US VIA A MAUDE EVENT REPORT # (B)(4). THE EXACT INSTRUMENT IS UNKNOWN AT THIS TIME IT WAS REPORTED AS A RHOTON HOOK. IT WAS REPORTED: "THE PATIENT IS A FEMALE WHO HAD UNDERGONE A CERVICAL ANTERIOR DISKECTOMY AND FUSION ON 2013. DURING THE PROCEDURE, ONE OF THE INSTRUMENTS BROKE AT THE TIME OF THE PROCEDURE. DESPITE MULTIPLE X-RAYS, I WAS NOT ABLE TO VISUALIZE THE RETAINED FRAGMENT OF THE INSTRUMENT. POSTOPERATIVELY I OBTAINED A CT SCAN THAT SHOWED THAT THE RETAINED FRAGMENT WAS IN THE SUPERFICIAL TISSUES OF THE NECK. I THEN DISCUSSED WITH THE PT THE OPTION OF GOING FORWARD WITH ATTEMPTED RE-EXPLORATION AND REMOVAL OF THE FRAGMENT SINCE THE FRAGMENT COULD POTENTIALLY RESULT IN HER INABILITY TO GET MRIS IN THE FUTURE ALONG WITH OTHER POSSIBILITIES. THE PATIENT STATED SHE WOULD LIKE TO GO FORWARD WITH T ATTEMPTED REMOVAL OF THE FRAGMENT. SHE WAS ALSO INFORMED THAT LEAVING THE FRAGMENT IN PLACE WOULD LIKELY RESULT IN NO HARM TO THE PT.  HOWEVER, SHE WOULD NOT BE A CANDIDATE FOR MRI SINCE LIT IS MADE OF (B)(4). THE PATIENT AND HER FAMILY STATE THEY HAD A FULL UNDERSTANDING OF THIS. THEY ALSO UNDERSTOOD THAT THERE WAS POSSIBILITY I WOULD NOT BE ABLE TO FIND THE FRAGMENT PRIOR TO GOING FOR SURGERY. INFORMED CONSENT WAS THEN OBTAINED."

Additional Manufacturer Narrative

CFN-2013-1810, SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. IF THE EXACT DEVICE IS MADE AVAILABLE A FOLLOW UP MDR WILL BE SENT WITH ADDITIONAL INFORMATION.