MalfunctionONN
LANTERN HIP
Received Jan 23, 2025 · Event occurred Jan 9, 2025
Report 3007521480-2025-00002 · MDR key 21223490
Device
Generic name
Surgical Navigation System
Manufacturer
Orthalign, Inc.Model number
502000-01Catalog number
502000-01
Lot number
2410112LS
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SURGEON. IS REPORTING THAT THE NUMBERS DO NOT ADD UP. THE CASE WAS COMPLETED WITH LANTERN HIP, BUT A C-ARM WAS USED TO VERIFY IMPLANT POSITIONING.
Additional Manufacturer Narrative
AT THIS TIME THE DEVICE HAS BEEN RETURNED TO ORTHALIGH FOR EVALUATION BY AN ORHTALIGN ENGINEER, BUT THE INVESTIGATION HAS NOT BEEN COMPLETED. UPON THE COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED DETAILING THE CONCLUSIONS, INCLUDING WHETHER THE COMPLAINT COULD BE CONFIRMED AND ROOT CAUSE IF AVAILABLE.