CAPSTONE PTC™ Spinal System 3992213Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 3992213 22MM 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
- 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 00643169187504), received between Dec 22, 2020 and Dec 22, 2020 — 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2020Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED POST-OP A PLIF PROCEDURE ON L5-S1 IN A PATIENT DIAGNOSED WITH STENOSIS. IT WAS REPORTED THAT THE CAGE BACKED OUT DURING HOSPITALIZATION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE CAGE AND 3 SCREWS ON RIGHT L5, LEFT AND RIGHT S1 WERE REPLACED AND AUTOGRAFT WAS IMPLANTED. THERE WAS NO MALFUNCTION ON THE PRODUCT. EXPLANTED CAGE WAS HANDED OVER TO THE CUSTOMER AND WILL NOT BE RETURNED. HEALTH DAMAGE WAS REPORTED IN THE PATIENT.
Patient problems: Pain
MAUDE report 11053491 ↗
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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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