CAPSTONE PTC™ Spinal System 3992212Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 3992212 22MM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169187511), received between May 11, 2020 and Mar 19, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 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
- Use of Device Problem2
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE EXPIRED BEFORE IT WAS SHIPPED OUT. PRODUCTS WERE USABLE AT ONE POINT THEN THEY EXPIRED. 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 21642672 ↗MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE EXPIRED BEFORE IT WAS SHIPPED OUT. PRODUCTS WERE USABLE AT ONE POINT THEN THEY EXPIRED. 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 21642654 ↗InjuryMay 11, 2020Migration; Migration
PRE-OPERATIVE DIAGNOSIS: STENOSIS PROCEDURE PERFORMED: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) LEVELS IMPLANTED: L5 AND S1 POST-OP, CAGE ON ONE SIDE OF L5/S1 WAS BACKED OUT. AS THE BACKED-OUT CAGE HAD NO BREAKAGE AND THE AMOUNT OF MIGRATION WAS SMALL SO THE CAGE WAS PUSHED IN AND CONTINUED TO BE USED.
Patient problems: Pain
MAUDE report 10041867 ↗
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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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