MalfunctionNKB
UCENTUM
Received Apr 28, 2022 · Event occurred Mar 28, 2022
Report 9612420-2022-00004 · MDR key 14241912
Device
Generic name
Screw, Polyaxial, Cannulated, Fenestrated
Manufacturer
Ulrich Gmbh & Co. KgModel number
CS 3802-065-050Catalog number
CS 3802-065-050
Lot number
U0020814
Product problems
- Fracture
- Fracture
Patient
Prefer Not To Disclose
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
UCENTUM PEDICLE SCREW: WHEN UNSCREWING THE PEDICLE SCREW, THE SCREW TIP BROKE OFF IMMEDIATELY AT THE CEMENT PERFORATIONS. THE RESIDUAL SCREW REMAINED IN THE PATIENT.