ELEVATE™ Spinal System 7770928Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 7770928 ELEVATE STD 28X9MM · 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 00643169430693), received between Apr 12, 2021 and Apr 12, 2021 — 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.
Most reported problems
Device problems
- Break2
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.
MalfunctionApr 12, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING A PROCEDURE OF MAST TRANSFORAMINAL LUMBAR INTERBODY FUSION AT THE LEVELS OF L3 -L4. THE PRE-OPERATIVE DIAGNOSIS WAS LUMBAR SPONDYLOSIS WITH RADICULOPATHY. IT WAS REPORTED THAT, THE PEEK TABS BROKE OFF FROM CAGE UPON IMPACTION TWICE. SO, THEY USED AN 8MM ELEVATE AND IT WAS SUCCESSFULLY IMPLANTED. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11648110 ↗MalfunctionApr 12, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING A PROCEDURE OF MAST TRANSFORAMINAL LUMBAR INTERBODY FUSION AT THE LEVELS OF L3 -L4. THE PRE-OPERATIVE DIAGNOSIS WAS LUMBAR SPONDYLOSIS WITH RADICULOPATHY. IT WAS REPORTED THAT, THE PEEK TABS BROKE OFF FROM CAGE UPON IMPACTION TWICE. SO, THEY USED AN 8MM ELEVATE AND IT WAS SUCCESSFULLY IMPLANTED. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11648048 ↗
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- 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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