Annex® Adjacent Level System 11-5052Recalls & reported problems
Spine Wave, Inc. · Implant No Jog Straight 5.5x50mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840642102758), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Detachment of Device or Device Component
APPROXIMATELY THREE MONTHS POST-OPERATIVELY FOLLOWING A PROCEDURE TO EXTEND AN EXISTING PEDICLE SCREW CONSTRUCT, A PATIENT REPORTED PAIN. ON RADIOGRAPH, THE ROD CONNECTORS WERE OBSERVED TO BE DISENGAGED FROM THE RODS IN THE PEDICLE SCREW CONSTRUCT. A PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE SUBJECT DEVICE.
Patient problems: Pain
MAUDE report 24485047 ↗
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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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