CORNERSTONE® PSR System 6279002Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSERTER 6279002 PSR ENDCAP THREADED · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885074354323), received between Mar 16, 2026 and May 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING AN INSERTER USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT STRIKE PLATE ON INSERTER SHAFT BROKE OFF. INSTRUMENT BROKE ON BACK TABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137652 ↗MalfunctionApr 7, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT DURING FIELD CONTACT, THE FOLLOWING DEVICE-RELATED ISSUES AND MALFUNCTIONS WERE IDENTIFIED: THE SLEEVE 7967028 INSERTER WOULD NOT ATTACH WITH TRIAL, THE SHAFT 2161001 OLIF25 INTERBODY THREADED HAD A TIP THAT BROKE OFF, THE INSERTER 4360113 13MM INSERTER CASE WAS NOT ATTACHING, AND THE DRIVER 6630904 T8/T10 DRIVER WAS STRIPPED. TIP BROKE OFF FOR INSERTER 6279002 PSR ENDCAP THREADED. DRIVER 7080907 2.5 HEX SCREWDRIVER (QTY-2) WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24804429 ↗MalfunctionMar 30, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING THE PATIENT USING CERVICAL CORPECTOMY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR S YMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24711068 ↗MalfunctionMar 16, 2026Break
INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY PROCEDURE. IT WAS REPORTED THAT THE ENDCAP PORTION OF THE INSTRUMENT BROKE OFF FROM THE THREADED SHAFT PORTION.THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24602466 ↗
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- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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