MalfunctionNKB

CARBOCLEAR X

Received Mar 31, 2022 · Event occurred Nov 30, 2021

Report MW5108703 · MDR key 13976897

Device

Generic name

Thoracolumbosacral Pedicle Screw System

Manufacturer

Carbofix Orthopedics, Ltd.

Product problems

Break
Difficult to Remove

Patient

Prefer Not To Disclose

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CARBOFIX MANUFACTURERS IN (B)(4) AND SELLS PRODUCT IN THE US. THEIR NEW CARBON FIBER TULIP BROKE OFF FROM THE SCREW. SCREW NEEDED TO BE REMOVED WITH QUITE A BIT OF DIFFICULTY. FDA SAFETY REPORT ID # (B)(4).