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OrthAlign Plus 403028Recalls & reported problems

Orthalign, Inc. · Adapter,Implant,Str Impactr,3/8-24,S/B · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858704006565), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hip Fracture1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. AFTER CUP IMPACTION WITH 48MM CUP, THE SURGEON TRIED TO DISENGAGE FROM CUP AND IMPACTOR. HOWEVER, HE WAS UNABLE TO DISASSEMBLE THE CUP. SUBSEQUENTLY, TWO SURGEONS DISENGAGED THE CUP WITH FORCE. THE PATIENT ACETABULAR WAS LITTLE DAMAGED BY DISASSEMBLY SO BIGGER CUP (50MM) WAS USED TO COMPLETE THE PROCEDURE.

    Patient problems: Hip Fracture; No Clinical Signs, Symptoms or Conditions

    MAUDE report 10377134 ↗

Other Orthopedic Stereotaxic Instrument devices

All Orthopedic Stereotaxic Instrument devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.