ELEVATE™ Spinal System 7770732Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 7770732 ELEVATE X-LOR 32X7MM · Class 2 · Implant
All models of ELEVATE Spinal System (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169430723), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2020Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF DEGENERATIVE DISC DISEASE (DDD) INVOLVED IN MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED DURING INTRA-OP, SCREW SHEARED OFF WHILE EXPANDING. INSTRUMENT DID NOT BREAK, AND THERE IS NO FRAGMENT LEFT IN THE PATIENT¿S BODY. THERE IS NO PATIENT SYMPTOMS, OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE IS NO REVISION SURGERY, OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THE EVENT. FURTHER, THERE IS NO COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PATIENT IS ALIVE, AND NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10654530 ↗
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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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