MalfunctionNKB
UCENTUM
Received Nov 3, 2021 · Event occurred Sep 30, 2020
Report 9612420-2021-00012 · MDR key 12749075
Device
Generic name
Longarm Screw, Polyaxial, Ø 8.5 Mm, Length 45 Mm, Not Cannulated
Manufacturer
Ulrich Gmbh & Co. KgModel number
CS 3885-085-045Catalog number
CS 3885-085-045
Lot number
U017218
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
MDR SHOULD NOT HAVE BEEN SUBMITTED. AFTER GETTING A HOLD OF THE USER, WE DISCOVERED THAT THE PEDICLE SCREW CAME APART PRIOR TO SURGERY, NOT IN THE SURGICAL FIELD, AND THERE WAS NO EFFECT ON THE PATIENT.
Description of Event or Problem
SCREW CAME APART DURING IMPLANTATION AND HAD TO BE REMOVED AND REPLACED.