2.7MM X 12MM NL HEXALOBE COCR SCREW
Received Jul 15, 2026 · Event occurred Jun 26, 2026
Report 3025141-2026-00361 · MDR key 25827196
Device
Generic name
Screw, Fixation, Bone
Manufacturer
Acumed, LlcModel number
3061-27012Lot number
NOT REPORTED
Product problems
- Break
Patient
NA · Female
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION AND HAS BEEN REPORTED TO ACUMED THAT IT WILL NOT BE RETURNED, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON HAD SCREWS IN AND THE COCR DID NOT SIT IN THE PLATE AS FLUSH AS THE TITANIUM SCREWS. HE TRIED TO CRANK DOWN ON IT TO SET THE SCREW BETTER AND IT BROKE OFF. 2.7MM COCR SCREW BREAKAGE WITH A VDR PLATE NL AND STEM LEFT IN SITU. THERE WAS A REPORTED DELAY OF 15-30 MINUTES.