OrthAlign Plus 403001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00858704006534), received between Nov 8, 2017 and Oct 12, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2023Incorrect Measurement; Incorrect Measurement

  EVERYTHING CALIBRATED FINE, BUT THE CUT ON THE FEMUR WAS SIGNIFICANTLY OFF. THE SURGERY WAS COMPLETED WITH STANDARD INSTRUMENTS.

  Patient problems: Joint Laxity

  MAUDE report 17920461 ↗
• MalfunctionOct 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SUMMARY SCREEN FLEXION EXTENSION NUMBERS DID NOT MATCH THE PREVIOUS ORIGINALLY REGISTERED FLEXION EXTENSION NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719478 ↗
• MalfunctionAug 5, 2021Communication or Transmission Problem; Communication or Transmission Problem

  AN ORTHALIGN PLUS NAVIGATION UNIT SET THE DISTAL FEMORAL VALGUS ANGLE SO FAR OFF THAT IT'S BEEN VISIBLY INCORRECT FROM A DISTANCE (15 DEGREES OR MORE). REP CHECKED AND ASSISTED NURSE WITH SET UP AND CALIBRATION, ALL STEPS FOLLOWED AS PER TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285342 ↗
• MalfunctionMay 16, 2018Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem

  ORTHALIGN NAVIGATION UNIT SHOWED A SYSTEM FAULT 6 DURING CALIBRATION, PRIOR TO PATIENT USE. WHEN OBTAINING THE CUP ANGLE THE NAVIGATION UNIT SCREEN DISPLAYED "SYSTEM UNSTABLE" AND WOULD NOT DISPLAY ANGLES. WHEN OBTAINING LEG LENGTH THE NAVIGATION UNIT DISPLAYED A MEASUREMENT OF 141 MM SHORTER AT THE END OF THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7520582 ↗
• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT A FRACTURE IN THE TIBIA OCCURRED DURING PLACEMENT OF THE TIBIAL CUTTING BLOCK DURING AN UNICOMPARTMENTAL KNEE ARTHROPLASTY PROCEDURE NAVIGATED BY THE ORTHALIGN PLUS SYSTEM. THE FRACTURE REQUIRED USE OF A SMALL FRAGMENT PLATE AND SCREWS TO STABILIZE THE PROXIMAL TIBIA BELOW THE RESECTION SITE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7012102 ↗
• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT A PATIENT WHO HAD UNDERGONE AN UNICOMPARTMENTAL KNEE ARTHROPLASTY PROCEDURE NAVIGATED BY THE ORTHALIGN PLUS SYSTEM RETURNED THREE AND A HALF MONTHS LATER WITH A FRACTURE IN THE TIBIA BELOW THE TIBIAL RESECTION. THE FRACTURE REQUIRED A REVISION PROCEDURE WITH A LONG TIBIAL STEM TO CONSTRAIN THE ARTHROPLASTY COMPONENTS AND BYPASS THE FRACTURE SITE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7011820 ↗