inforMED
InjuryNKB

UCENTUM

Received Nov 11, 2022 · Event occurred Oct 10, 2022

Report 3005823819-2022-00023 · MDR key 15780409

Device

Generic name

Screw, Polyaxial, Cannulated, Fenestrated

Model number

CS 3802-065-055

Catalog number

CS 3802-065-055

Lot number

U034491

Product problems

  • Fracture
  • Fracture

Patient

Unknown

  • Failure of Implant
  • Failure of Implant

Narrative

Description of Event or Problem

PEDICLE SCREW FRACTURE AT JUST UNDER 12 WEEKS POST-OP. NO TRAUMA.