7D Surgical Pedicle Probe (Lumbar) 11-0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00628341520027), received between Mar 10, 2025 and Aug 20, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Fracture

  On 22 JUL 2026 Orthofix was made aware of an event involving the 7D Surgical Pedicle Probe (Lumbar) fracturing during a lumbar fusion revision procedure. The reporter stated that while advancing the probe through highly sclerotic sacral bone, the shaft of the probe would not rotate with the handle. Upon removal, it was observed that the distal end had twisted, and the tip had fractured off. The fragment remained within the bone.No patient injury was reported. The surgeon did not attempt to retrieve the fragment.

  Patient problems: Foreign Body In Patient

  MAUDE report 50358999 ↗
• MalfunctionAug 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 30 JUL 2025, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT DURING NAVIGATION USING 7D SURGICAL FLASH IMAGING. PER THE REPORTER, THE SURGEON NAVIGATED THE RIGHT T10 AND RIGHT T9 SCREWS USING THE 7D SURGICAL PEDICLE PROBE (LUMBAR). THE SURGEON COMPLAINED OF THE PROBES INACCURACY AND SWITCHED TO ANOTHER PROBE TO COMPLETE THE REMAINING SCREW NAVIGATION. AFTER ALL SCREWS WERE IMPLANTED, AN X-RAY WAS TAKEN, REVEALING THAT THE T10 AND T9 SCREWS WERE INCORRECTLY POSITIONED. THE TWO SCREWS WERE REVISED, RESULTING IN A 45 MIN SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913121 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  THE CUSTOMER REPORTED THAT WHILE CANNULATING THE PATIENT'S PELVIS, THE SURGEON FELT A SNAP. WHEN HE PULLED THE INSTRUMENT OUT, HE FOUND THAT THE TIP OF THE PROBE HAD SNAPPED OFF. THE SURGEON PROCEEDED WITH NAVIGATION. APPROXIMATELY 10 MM OF THE INSTRUMENT TIP WAS LEFT 110MM DEEP IN THE PATIENT'S PELVIS. NO PATIENT INJURY WAS REPORTED. NO REVISION SURGERY IS NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 21564523 ↗