Crescent Spinal System Titanium X0610004Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER X0610004 CRESCENT PK TAPERD 30X10 · Class 2 · Implant
Data updated Oct 13, 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 00613994880116), received between May 24, 2022 and May 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
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.
MalfunctionMay 24, 2022Crack; Crack
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR SPINAL SURGERY. PROCEDURE PERFORMED IN THE EVENT WAS TLIF. 1 LEVELS IMPLANTED. IT WAS REPORTED THAT INTRA-OPERATIVELY, DURING INSERTION WHILE ON INSERTER THE IMPLANT CRACKED, AND A SMALL PORTION WAS REMOVED. SURGEON LEFT REMAINING PORTION OF THE IMPLANT IN PLACE. THE IMPLANT WAS NOT COMPLETELY REMOVED FROM PATIENT. A VERY SMALL PIECE OF THE IMPLANT WAS REMOVED AND DISCARDED. SURGEON SPENT ABOUT 30 MINUTES TRYING TO REMOVE THE IMPLANT BEFORE DECIDING TO LEAVE IT IN PLACE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14490095 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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