Novel 64920Recalls & reported problems
Alphatec Spine, Inc. · Novel Lumbar Inserter Assembly · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844856034884), received between Jul 12, 2016 and Oct 31, 2016 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break4
- Detachment Of Device Component1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2016Break; Fracture
AS THE SURGEON WAS INSERTING THE FIRST OF TWO CAGES, THE DISTAL THREADED TIP WHICH ATTACHES TO THE CAGE FRACTURED AND BROKE. THE TIP DETACHED AND REMAINED POSITIONED WITHIN THE CAGE UNTIL IT WAS DRILLED OUT AND REMOVED. THE ANGEL WAS TOUGH AND THE SITUATION COULD HAVE BEEN AVOIDED WITH ANGLED INSERTER. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.
Patient problems: No Code Available
MAUDE report 6067899 ↗MalfunctionOct 24, 2016Break; Detachment Of Device Component
THE TIP OF THE DRIVER BROKE OFF INSIDE THE TRIAL WHILE REMOVING IT FROM THE DISK SPACE. THE FRACTURED SECTION AND THE TRIAL IN WHICH IT WAS POSITIONED WHERE BOTH REMOVED FROM THE PATIENT WITHOUT ISSUE. THE EVENT CAUSED NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6051568 ↗MalfunctionAug 29, 2016Break
THE INNER DRIVER TIP BROKE IN SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5912466 ↗MalfunctionJul 12, 2016Break
THE TIP OF A NOVEL INSERTER WAS DISCOVERED BROKEN DURING A ROUTINE INSPECTION.
Patient problems: No Patient Involvement
MAUDE report 5787248 ↗
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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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