inforMED
MalfunctionHAW

NDI PASSIVE SPHERES

Received May 5, 2015 · Event occurred Mar 23, 2015

Report 3002743211-2015-00022 · MDR key 4749163

Device

Generic name

Reflective Passive Marker Spheres

Model number

8801075

Lot number

1408281/1409021

Product problems

  • Communication or Transmission Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE ((B)(6) HOSPITAL) HAD SPHERES THAT WOULD NOT TRACK. SITE REPLACED SPHERES ON INSTRUMENT AND CASE PROCEEDED. SITE DISPOSED OF SPHERES AND DID NOT TAKE ANY PICTURES OF THE SPHERES. COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE EVENT TO THE PATIENT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.