LANTERN HIP
Received Jan 17, 2025 · Event occurred Dec 23, 2024
Report 3007521480-2025-00003 · MDR key 21182485
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
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO ORTHALIGN AND WAS EVALUATED BY AN ORTHALIGN ENGINEER. THE NAVIGATION LOGS WERE DOWNLOADED AND NOT ANOMALIES WERE FOUND. THE SYSTEM WAS TESTED FOR ACCURACY AND MET ALL ACCEPTANCE CRITERIA. THIS COMPLAINT IS NOT CONFIRMED. THE ISSUE COULD NOT BE REPLICATED AND NO ROOT CAUSE COULD BE IDENTIFIED.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED TO ORTHALIGN FOR EVALUATION AND AN INVESTIGATION WAS COMPLETED BY AN ORTHALIGN ENGINEER. THE LOGS WERE REVIEWED FOR ANY ANOMALIES AND ACCURACY TESTING WAS CONDUCTED. GIVEN THE SYSTEM INPUTS THE LOGS SHOWED THE EXPECTED SYSTEM OUTPUTS. ACCURACY TESTS WERE SUCCESSFUL AS WELL .THE COMPLAINT WAS NOT CONFIRMED AND NO ROOT CAUSE WAS ESTABLISHED. A POSSIBLE ROOT CAUSE IS USER ERROR. ORTHALIGN WILL CONTINUE TO MONITOR THE COMPLAINT DATA AND TAKE ACTION IF DEEMED NECESSARY.
Description of Event or Problem
NUMBERS SEEMED OFF, SPECIFICALLY THE OFFSET NUMBERS. WHEN THE DOCTOR SWITCHED FROM A VARUS TO A VALGUS NECK, THE OFFSET NUMBERS DID NOT CHANGE.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED TO ORTHALIGN FOR EVALUATION AND AN INVESTIGATION WAS COMPLETED BY AN ORTHALIGN ENGINEER. THE LOGS WERE REVIEWED FOR ANY ANOMALIES AND ACCURACY TESTING WAS CONDUCTED. GIVEN THE SYSTEM INPUTS THE LOGS SHOWED THE EXPECTED SYSTEM OUTPUTS. ACCURACY TESTS WERE SUCCESSFUL AS WELL .THE COMPLAINT WAS NOT CONFIRMED AND NO ROOT CAUSE WAS ESTABLISHED. ORTHALIGN WILL CONTINUE TO MONITOR THE COMPLAINT DATA AND TAKE ACTION IF DEEMED NECESSARY.
Description of Event or Problem
NUMBERS SEEMED OFF, SPECIFICALLY THE OFFSET NUMBERS. WHEN THE DOCTOR SWITCHED FORM A CARUS TO A CALGUS NECK, THE OFFSET NUMBERS DID NOT CHANGE.