CAPSTONE PTC™ Spinal System 3992214Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 3992214 22MM X 14MM · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169187498), received between Jun 28, 2022 and Jun 28, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration1
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.
InjuryJun 28, 2022Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT PATIENT REPORTED FEELING POP. UPON FURTHER EVALUATION, PHYSICIAN DISCOVERED BY X-RAY THAT A SET SCREW HAD COME LOOSE AND CAGE HAD BACKED OUT. THE DEVICES WERE EXPLANTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE: PROCEDURE INVOLVED - L4-S1 TLIF THERE WAS A DELAY IN THE PROCEDURE BY MORE THAN 60 MINS, AS REVISION SURGERY HAD TO BE PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14839686 ↗
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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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