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CRESCENT™ Spinal System 9392512Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 9392512 CRESCNT SPNAL SYSTM 25X12 · Class 2 · Implant

All models of CRESCENT Spinal System (18)

Data updated Oct 16, 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 00613994187505), received between Dec 11, 2019 and Dec 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Device problems

  • Fracture1
  • Material Deformation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionDec 11, 2019Fracture; Material Deformation; Fracture; Material Deformation

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SPINAL CANAL DECOMPRESSION POSTERIOR FIXATION FUSION AT L4-5, S1 DUE TO SPINAL STENOSIS. INTRA-OP, SPACER WAS DEFORMED AT THE CONNECTION SITE AND FRACTURED DURING IMPLANTATION. NO ANY FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9449521 ↗

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Sources and updates

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