MalfunctionDZJ
ACCUPLAN, ACCUPLATE 3DTI
Received Mar 10, 2026 · Event occurred Feb 12, 2026
Report 3009196021-2026-00006 · MDR key 24558477
Device
Generic name
Titanium Hybrid Guide And 3d Printed Titanium Lefort Plate
Manufacturer
MedcadModel number
ZB-KT001-H, ZB-3DT011Catalog number
ZB-KT001-H, ZB-3DT011
Lot number
262733SIE
Product problems
- Positioning Problem
Patient
26 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS CONFIRMED BY THE SALES REP. THAT THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH A SLIGHT DELAY AND THE MISALIGNMENT DID NOT AFFECT THE SURGICAL OUTCOME. NO ADDITIONAL SURGERY REQUIRED.
Description of Event or Problem
THE PREDICTIVE HOLES DIDN'T ALIGN WITH THE PLATE.