OrthAlign Plus 403087-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00851977007888), received between Oct 30, 2020 and Oct 22, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (15 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  VERSION NUMBERS KEPT DRIFTING TO ZERO THROUGHOUT THE CASE. NO IMPACT TO PATENT. CASE COMPLETED WITH CONVENTIONAL INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505626 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ALIGNMENT READINGS ARE OFF. WHEN SETTING UP FOR THE CORRECT SIDED HIP THE NUMBERS ON THE NAV UNIT SHOW RETROVERTED. RELATED TO REPORTS 3007521480-2023-00017 AND 3007521480-2023-00018.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016217 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ALIGNMENT READINGS ARE OFF. WHEN SETTING UP FOR THE CORRECT SIDED HIP THE NUMBERS ON THE NAV UNIT SHOW RETROVERTED. RELATED TO REPORTS 3007521480-2023-00017 AND 3007521480-2023-00019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015450 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ALIGNMENT READINGS ARE OFF. WHEN SETTING UP FOR THE CORRECT SIDED HIP THE NUMBERS ON THE NAV UNIT SHOW RETROVERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012027 ↗
• MalfunctionAug 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SURGEON POSITIONED THE CUP PER THE TECHNIQUE. THE FIRST TIME CUP WAS REGISTERED WITH NO INCIDENT. THE SECOND TIME THE CUP WAS REGISTERED IT STARTED AT A NORMAL VALUE BUT THEN QUICKLY STARTED TO DRIFT AWAY TO DIFFERENT VALUES. THE DRIFT WAS LIKELY 10 DEGREES OF ANTEVERSION BEFORE THE 30 SECOND TIMER ENDED. THE THIRD TIME THE DRIFT WAS NOT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200205 ↗
• MalfunctionDec 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN WE WERE DOING A DA HIP PROCEDURE THE FINAL LEG LENGTH AND OFFSET WERE VERY FAR OFF NORMAL READINGS. THE READINGS FOR LEG LENGTH WERE 20MM LONGER AND 41MM MEDIAL. I REQUESTED HE START AGAIN TO SEE IF WE GOT THE SAME READINGS TWICE. WE GOT THE SAME READINGS TWO TIMES IN A ROW. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122728 ↗
• MalfunctionNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BOTH SENSORS GAVE INVERTED/RETROVERTED READING FOR THE CUP. THE REP, STAFF AND SURGEON INSIST THE CUP ADAPTOR WAS FACING THE CORRECT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830846 ↗
• MalfunctionNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BOTH SENSORS GAVE INVERTED/RETROVERTED READING FOR THE CUP. THE REP, STAFF AND SURGEON INSIST THE CUP ADAPTOR WAS FACING THE CORRECT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830841 ↗
• MalfunctionOct 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  IT WAS REPORTED THAT THE UNIT DOESN'T WORK. THE SENSOR WAS NOT PROVIDING ACCURATE RESULTS. THE CUPS VERSION AND ABDUCTION WAS JUST WAY OFF FROM THE STATED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697624 ↗
• MalfunctionAug 10, 2021No Apparent Adverse Event; No Apparent Adverse Event

  WHILE PERFORMING THE ACETABULAR NAVIGATION THE SURGEON;S CUP READING WAS 22/13 AFTER USING XRAY VALIDATION HE FELT THATHIS NUMBERS WERE CLOSER TO 40/13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301633 ↗
• MalfunctionAug 5, 2021Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT DURING THA PROCEDURE, AFTER PUTTING ONE REFERENCE SENSOR (SERIAL # (B)(4)) ON THE IMPACTOR THE CUP READ 38 ABDUCTION AND 9 DEGREES OF ANTEVERSION THEN PROCEEDED TO MARCH DOWN TO 8 DEGREES ANTEVERSION, 7, THEN 6 ALL THE WAY TO 3 IN 15 SECONDS. THE SECOND REFERENCE SENSOR (SERIAL # (B)(4)) READ 45 DEGREES ABDUCTION AND 25 ANTEVERSION BUT MARCHED DOWN STEADILY TO ABOUT 20 DEGREES ANTEVERSION (AND NO MOVEMENT OF ANYTHING). SURGEON REPEATED (IMPACTOR DIDN'T MOVE) AND SAME THING 45/25 EXCEPT THIS TIME IT MARCHED UP TO 45/30. REPEATED A THIRD TIME AND FINALLY IT WAS ROCK STEADY AT 45/26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285141 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936498 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936458 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936454 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936394 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936353 ↗
• MalfunctionDec 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936337 ↗
• MalfunctionOct 30, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SENSOR GAVE VERY INACCURATE CUP PLACEMENT READINGS. NAV UNIT HAD BATTERY ISSUES, AND POWERED DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10764748 ↗