Device Problems
Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
Patient Problem
Paralysis (1997)
Event Date 07/09/2014
Event Type
Injury
Event Description
Letter was receive via (b)(6) from competitor company, it was reported "surgical outcome resulted in a paralysis following anterior cervical discectomy and fusion (acdf) with aviator plate and screws.
(competitor's device) and integra-stackable peek device.
It appears the integra corpectomy device retropulsed resulting in loss of signals as noted by biotronics".
Manufacturer Narrative
The device involved in the reported incident is not available for eval.
An investigation has been initiated based on the reported info.