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DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2151100Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSERTER 2151100 HANDLE INSERTER · Class 2

All models of DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (14)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169524682), received between Oct 19, 2021 and Oct 19, 2021 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • 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.

  • MalfunctionOct 19, 2021Break; Break

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER HANDLE INSTRUMENT BROKE AND THE MAIN SCREW FOR THE PITUITARY RONGEUR INSTRUMENT FELL OUT DURING USE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12653043 ↗

Other Intervertebral fusion device with integrated fixation, lumbar devices

All Intervertebral fusion device with integrated fixation, lumbar devices →

Sources and updates

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