ELEVATE™ Spinal System 7770832Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 7770832 ELEVATE STD 32X8MM · Class 2 · Implant
All models of ELEVATE Spinal System (33)
Data updated Oct 16, 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 00643169430730), received between May 31, 2018 and Jun 26, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2019Crack; Crack
IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) DUE TO STENOSIS AT L5/S1. INTRA-OP, THE PEEK PORTION OF THE CAGE CRACKED UPON INSERTION, BEFORE IT ADVANCED INTO THE DISC SPACE. IT WAS REMOVED FROM THE PATIENT BODY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8734192 ↗MalfunctionMay 31, 2018Break; Break
IT WAS REPORTED THAT INTRA-OP, CAGE WAS LOADED PROPERLY AND DURING INSERTION THE PEEK COMPONENT BROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7559079 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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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
- 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
- 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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