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NA 202918Recalls & reported problems

Depuy Spine, LLC · SPINAL INSTRUMENT DIAMOND HEAD ELEVATOR 19.05mm · 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 10705034000770), received between Apr 26, 2019 and Apr 26, 2019 — 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

  • Injury1
  • Pain1
  • Swelling1

Recent adverse event reports

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

  • InjuryApr 26, 2019Break; Break

    IT WAS REPORTED DURING REVISION SURGERY, DOCTOR WAS USING DIAMOND COBB ELEVATOR. WHILE DOCTOR WAS ACCESSING DISC SPACE, THE DEVICE BROKE IN TWO WITH A THIRD PIECE REMAINING IN DISC SPACE. WHEN THE STAINLESS STEEL TOOL BROKE, IT SEVERED THE VEINS GOING DOWN PATIENT'S BACK AND CAUSED SIGNIFICANT INTERNAL BLEEDING. AS A RESULT, PATIENT WAS LEFT WITH A BLOOD CLOT IN LEFT LEG, SWELLING AND PAIN.

    Patient problems: Injury; Pain; Swelling

    MAUDE report 8557259 ↗

Other ELEVATOR devices

All ELEVATOR devices →

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