KIT DUALX LLIF 8-11MM x 7 DEG x 45MM 12833007002Recalls & reported problems
Amplify Surgical, Inc. · LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 8-11mm x 7° x 45mm Collapsed Width (mm): 13.34 Expanded Width (mm): 22 Collapsed Height (mm): 8.5 Expanded Height (mm): 11.5 Collapsed Length (mm): 53.76 Expanded Length (mm): 46.8 LLIF SCREW - 45MM · Class 2 · Implant
Data updated Oct 18, 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 B707128330070020), received between Apr 16, 2021 and Apr 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2021Device Markings/Labelling Problem
SURGEON NOTICED THAT DIRECTION INDICATOR WAS FLIPPED WITH ANTERIOR MARKED ON POSTERIOR SIDE AND POSTERIOR MARKED ON ANTERIOR SIDE. SURGEON IMPLANTED DEVICE IN CORRECT ORIENTATION IGNORING INCORRECT INDICATOR.
Patient problems: Insufficient Information
MAUDE report 11682363 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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