CAPSTONE PTC™ Spinal System 3992612Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 3992612 26MM X 12MM · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169187405), received between Apr 18, 2022 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Difficult to Advance1
- Mechanics Altered1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 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 50954594 ↗MalfunctionMar 25, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT IMPLANT WAS EXPIRED. EXPIRED ON (B)(6) 2024. IMPLANT REMAINS IN PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE GRAFT WAS NOT RECEIVED FROM MEDTRONIC IN EXPIRED CONDITION, IT WAS EXPIRED IN IMPLANT SUITCASE AND WAS USER ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690311 ↗MalfunctionApr 18, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS DEVICE DETACHMENT OUTSIDE THE PATIENT AFTER REMOVAL. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATED INFORMATION RECEIVED ON 08-APR-2022: THE USER FELT UNSTABLE BETWEEN CAPSTONE PEEK AND THREADED INSERTER WHEN HE IMPACT THE CAPSTONE PEEK INTERBODY SPACER, AND FIND OUT THE CAPSTONE PEEK SPLIT AFTER THEY IMPACT THE CAPSTONE PEEK INTERBODY SPACER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14133384 ↗
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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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