OrthAlign Plus 403185Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00858704006725), received between Oct 6, 2016 and Aug 9, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Separation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2018Material Separation; Material Separation

  DURING A PROCEDURE OF A NAVIGATED THA CASE, PERFORMED WITH ORTHALIGN PLUS NAVIGATION, A FIXATION PIN BROKE DURING ITS ATTEMPTED REMOVAL. THE PIN HAD BEEN USED TO FIXATE THE PELVIC BASE DURING THE AND BROKE NEAR THE SURFACE OF THE ILIAC CREST. UPON ATTEMPTED REMOVAL FROM THE PATIENT THE PIN FRAGMENTED IN TWO. THE PROXIMAL FRAGMENT WAS REMOVED AND HAS BEEN RETURNED TO ORTHALIGN FOR INVESTIGATION. THE DISTAL PORTION OF THE PIN REMAINS IN THE PATIENTS ILIAC WING.

  Patient problems: Foreign Body In Patient

  MAUDE report 7770470 ↗
• InjuryApr 22, 2017Material Separation; Material Separation

  A STAINLESS STEEL PIN USED TO MOUNT INSTRUMENTATION TO THE PATIENT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE BROKE DURING A REMOVAL ATTEMPT AT THE END OF THE PROCEDURE. THE PIN BROKE OFF FLUSH WITH THE BONE IN THE PATIENT'S ILIAC CREST. THE TOP PART OF THE PIN WAS REMOVED FROM THE PATIENT. THE DISTAL PART OF THE PIN REMAINED IN THE PATIENT'S BONE. NO ADDITIONAL SURGICAL STEPS OR PROCEDURES WERE CONDUCTED AS A RESULT OF THIS INCIDENT. NO ADDITIONAL COMPLICATIONS OR EFFECTS ON THE PATIENT WERE REPORTED. THE SURGEON ELECTED TO LEAVE THE PIN FRAGMENT IN THE BONE AND TO MONITOR PATIENT CONDITION DURING FOLLOW-UP VISITS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6514875 ↗
• InjuryMar 4, 2017Material Separation; Material Separation

  A STAINLESS STEEL PIN USED TO MOUNT INSTRUMENTATION TO THE PATIENT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE BROKE DURING A REMOVAL ATTEMPT AT THE END OF THE PROCEDURE. THE PIN BROKE OFF FLUSH WITH THE BONE IN THE PATIENT'S ILIAC CREST. THE TOP PART OF THE PIN WAS REMOVED FROM THE PATIENT. THE DISTAL PART OF THE PIN REMAINED IN THE PATIENT'S BONE. NO ADDITIONAL SURGICAL STEPS OR PROCEDURES WERE CONDUCTED AS A RESULT OF THIS INCIDENT. NO ADDITIONAL COMPLICATIONS OR EFFECTS ON THE PATIENT WERE REPORTED. THE SURGEON ELECTED TO LEAVE THE PIN FRAGMENT IN THE BONE AND TO MONITOR PATIENT CONDITION DURING FOLLOW-UP VISITS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6378731 ↗
• InjuryOct 6, 2016Material Separation; Material Separation

  AT THE COMPLETION OF A NAVIGATED THA CASE, A FIXATION PIN BROKE DURING REMOVAL. THE PIN BROKE NEAR THE SURFACE OF THE ILIAC CREST, AND SEPARATED INTO 2 FRAGMENTS. THE PROXIMAL FRAGMENT WAS REMOVED AND DISCARDED. THE DISTAL SECTION OF THE PIN WAS RETAINED IN THE PATIENT'S ILIAC WING.

  Patient problems: Foreign Body In Patient

  MAUDE report 6004057 ↗