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N/A 8350293Recalls & reported problems

Medtronic Sofamor Danek, Inc. · PROBE 8350293 LUMBAR · Class 1

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 00613994282675), received between Sep 2, 2020 and Sep 2, 2020 — classified as 1 injury.

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

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjurySep 2, 2020Break; Break

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION IN NEED OF L4-S1 TLIF PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE LUMBAR GEAR SHIFT BROKE OFF IN THE SACRUM. THE FRAGMENT OF THE DEVICE REMAINING IN THE PATIENT REPORTED. IT WAS TOO DIFFICULT TO REMOVE THE FRAGMENT FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 10480979 ↗

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.