XLIF 5029950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195377026255), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING AN EXTREME LATERAL INTERBODY FUSION, A SURGEON WAS UNABLE TO OBTAIN A COMPOUND MUSCLE ACTION POTENTIAL (CMAP) WHEN USING THE THIRD STIMULATED DILATOR IN A SERIES OF STIMULATED DILATORS. AFTER TROUBLESHOOTING THE DEVICE SET-UP, THE SURGEON FELT COMFORTABLE PROCEEDING. AFTER THE SURGEON PLACED THE K-WIRE AND BEGAN REGULAR STIMULATION, THE ASSOCIATED INSTRUMENTATION INDICATED THE DILATOR WAS IN CLOSE PROXIMITY TO A NERVE. THE SURGEON WAS ABLE TO OBTAIN DIRECTIONALITY FOR THE SIGNAL AND DID NOT SEE ANY ELECTROMYOGRAPHY (EMG) ACTIVITY AND WAS COMFORTABLE PROCEEDING. FOLLOWING THE CASE, THE PATIENT PRESENTED WITH A UNILATERAL MOTOR AND SENSORY ISSUES FROM THE LEFT HIP DOWN INCLUDING A DEFICIT IN WHICH THE PATIENT COULD NOT BEND THEIR KNEE BUT COULD BEND THEIR FOOT. DURING AN ELEVEN (11) DAY POST-OPERATIVE FOLLOW-UP, IT WAS INDICATED THAT THE PATIENT HAD NOT SEEN MUCH IMPROVEMENT AND WAS BEGINNING REHABILITATION.

  Patient problems: Nerve Damage

  MAUDE report 14960751 ↗