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NA 698202545Recalls & reported problems

Depuy Spine, LLC · MODIFIED INSTRUMENT PEDICLE PROBE · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034228440), received between May 22, 2019 and Sep 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SPINAL FUSION SURGERY THE PEDICLE FINDER TIP WAS BROKE. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MODIFIED INSTRUMENT PEDICLE PROB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12512398 ↗
  • MalfunctionMay 22, 2019Break; Break

    IT WAS REPORTED ON AN UNKNOWN DATE, THE GEARSHIFT BROKE IN THE PEDICLE SCREW. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8632223 ↗

Other PROBE devices

All PROBE devices →

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