V. MUELLER HOOKS
Received Apr 24, 2013 · Event occurred Apr 22, 2013
Report MW5029959 · MDR key 3084893
Device
Generic name
Rhoton Hook
Manufacturer
Care FusionProduct problems
- Break
Patient
53 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
THE PT IS A (B)(6) FEMALE WHO HAD UNDERGONE A CERVICAL ANTERIOR DISKECTOMY AND FUSION ON (B)(6) 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 REEXPLORATION 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 PT STATES THAT SHE UNDERSTOOD THE RISK OF THE PROCEDURE ALONG WITH THE INCREASED RISK OF INFECTION AND STATED SHE WOULD LIKE TO GO FORWARD WITH 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 IT IS MADE OUT OF STAINLESS STEEL. THE PT AND HER FAMILY STATE THEY HAD A FULL UNDERSTANDING OF THIS. THEY ALSO UNDERSTOOD THAT THERE WAS A POSSIBILITY I WOULD NOT BE ABLE TO FIND THE FRAGMENT PRIOR TO GOING FOR SURGERY. INFORMED CONSENT WAS THEN OBTAINED.