MalfunctionKWQ

NEXXT SPINE STRUXXURE

Received Aug 29, 2019 · Event occurred Aug 23, 2019

Report MW5089476 · MDR key 8949916

Device

Generic name

Appliance, Fixation, Spinal Intervertebral Body

Manufacturer

Nexxt Spine Llc

Product problems

Break

Patient

70 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PLACED THE 510K CLEARED HARDWARE ON SPINE. THE LOCKING MECHANISM (ANTI-BACKOUT) BROKE UPON ATTEMPTING TO LOCK SCREWS TO PLATE. FDA SAFETY REPORT ID# (B)(4).