CAPSTONE PTC™ Spinal System 3993209Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 3993209 32MM X 9MM · Class 2 · Implant
Data updated Oct 13, 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 00643169187337), received between Mar 15, 2022 and Jan 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR/ HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN TLIF SURGERY FOR A LUMBAR HIVD. IT WAS REPORTED THAT WHEN THE SURGEON IMPLANTED THE CAGE FULLY AND TRIED TO IMPACT THE CAGE DEEPER, THE TAIL OF CAGE WAS BROKEN. THE FRAGMENTS OF THE CAGE WERE REMOVED AND THE OPERATION WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187829 ↗MalfunctionMar 15, 2022Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR (DIS), HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT AFTER INSERTING THE IMPLANT COMPLETELY, THE SURGEON HAMMERED THE IMPLANT INSERTER, AND THE END OF IMPLANT WAS SPLIT. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.
MAUDE report 13768273 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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