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MERCURY 62085-040Recalls & reported problems

Spinal Elements, Inc. · Screw;Ø8.5 X 40MM MERCURY® CLASSIC POLYAXIAL SCREW · Class 2

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 00840606117890), received between Nov 30, 2022 and Nov 30, 2022 — 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
  • Fracture1
  • Mechanical Problem1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryNov 30, 2022Break; Fracture; Mechanical Problem; Break; Fracture; Mechanical Problem

    IN RESPONSE TO VOLUNTARY MEDWATCH REPORT (B)(4) RECEIVED FROM FDA, PATIENT UNDERWENT L4-S1 LUMBAR FUSION SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE S1 SCREW HAD FRACTURED AFTER SIX MONTHS ON (B)(6) 2022. THE SHANK OF THE 8.5MM BONE SCREW, REMAINS IN THE PATIENT.

    Patient problems: Failure of Implant

    MAUDE report 15889860 ↗

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