CAPSTONE PTC™ Spinal System 3992613Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 3992613 26MM X 13MM · Class 2 · Implant
All models of CAPSTONE PTC Spinal System (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169187399), received between Feb 16, 2021 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (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.
Reports received per month
Most reported problems
Device problems
- Mechanics Altered1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954684 ↗MalfunctionFeb 16, 2021Migration; Migration
INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT POST-OP, DISC SLIPPED OUT OF PLACE. PATIENT IS EXPERIENCING PAIN, AND IS HAVING A REVISION SURGERY IN THE FUTURE.
Patient problems: Pain
MAUDE report 11330959 ↗
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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 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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