Catalyft PL Expandable Interbody System 6069116Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 6069116 CATALYFT PL40 LONG 11MM · Class 2 · Implant
All models of Catalyft PL Expandable Interbody System (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000246853), received between Jun 6, 2024 and Jun 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 16, 2025Open, Classified
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Z-0580-2026 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Problem1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2025Mechanics Altered; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT SIX MONTHS AFTER A SPINAL PROCEDURE THE CAGE WAS FOUND TO HAVE FOLDED BACK INTO ITS ORIGINAL POSITION, THERE WAS A LOSS OF LORDOSIS, AND THE CAGE HAD CLOSED BY ITSELF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306118 ↗MalfunctionJun 6, 2024Mechanical Problem; Mechanical Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THE PROCEDURE INVOLVED WAS A MINIMALLY INVASIVE SURGICAL TRANSFORAMINAL LUMBAR INTERBODY FUSION MIS L4-5 TLIF ON (B)(6) 2024. THE PATIENT WAS DOING WELL POST-OP WITH THE RESOLUTION OF PRE-OP SYMPTOMS AND WAS CURRENTLY DOING PHYSICAL THERAPY AND WAS PROGRESSING WITH REHAB PROGRAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19474785 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- 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
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page