inforMED
InjuryNKB

UCENTUM

Received Feb 14, 2022 · Event occurred Jan 21, 2022

Report 3005823819-2022-00004 · MDR key 13529528

Device

Generic name

Screw, Polyaxial, Cannulated, Fenestrated

Model number

CS 3802-065-045

Catalog number

CS 3802-065-045

Lot number

U016569

Product problems

  • Fracture
  • Fracture

Patient

55 YR · Male

  • Failure of Implant
  • Failure of Implant

Narrative

Description of Event or Problem

APPROX. 2 YEARS AFTER IMPLANTATION THE POLYAXIAL SCREW FRACTURED BELOW THE TULIP IN L5, LEFT. DURING EXPLANTATION STILL A FRACTURE IN THE LOWER THIRD OF THE SCREW SHAFT. TIP OF SCREW COULD NOT BE REMOVED.