inforMED
MalfunctionNKG

ULRICH MEDICAL

Received May 14, 2025 · Event occurred Mar 16, 2025

Report 9612420-2025-00103 · MDR key 22018886

Device

Generic name

Screw, Ø 3.5 Mm, Length 14 Mm

Model number

CS 3902-35-14

Lot number

U044976

Product problems

  • Fracture
  • Fracture

Patient

70 YR · Male

  • Failure of Implant
  • Failure of Implant

Narrative

Description of Event or Problem

"BREAKAGE OF A PEDICLE-SCREW DURING SURGERY. THIS RESULTS IN A DELAY IN THE OPERATION TIME. ACCORDING TO REPORTING PERSON: "WE ARE VERY SORRY TO INFORM YOU THAT THE ITEM BROKE DURING THE SURGERY AND PART OF IT HAS BEEN LEFT INSIDE THE PATIENT.""

Description of Event or Problem

"BREAKAGE OF A PEDICLE-SCREW DURING SURGERY. THIS RESULTS IN A DELAY IN THE OPERATION TIME. ACCORDING TO REPORTING PERSON: "WE ARE VERY SORRY TO INFORM YOU THAT THE ITEM.... BROKE DURING THE SURGERY AND PART OF IT HAS BEEN LEFT INSIDE THE PATIENT.""