VITAL VUE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D10, G4, H3, H6 H3 EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. A VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE DEVICE HANDLE HAD BEEN MELTED AND THE POWER SOURCE INSIDE THE HANDLE HAD BEEN SEVERED IN HALF. FUNCTIONAL TESTING COULD NOT BE DONE BASED ON THE CONDITION THE DEVICE WAS RETURNED IN. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARD TO THE REPORTED CONDITION DUE TO NOT BEING ABLE TO TEST BECAUSE THE DEVICES POWER SOURCE WAS DAMAGED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING ANTERIOR CERVICAL DISCECTOMY AND FUSION, THE DEVICE MELTED ON TABLE. ANOTHER DEVICE WAS OPENED AND DID THE CASE. THE PROBLEM WAS DISCOVERED BEFORE THE PRODUCT WAS USED ON THE PATIENT.