ANODYNE Plate System 20445-18Recalls & reported problems
Corelink LLC · ANODYNE CERVICAL SCREW - FIXED SELF TAPPING - 4.5MM X 18MM · Class 2
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 M7252044518), received between Jul 7, 2017 and Jul 7, 2017 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionJul 7, 2017Break; Break
CUSTOMER ALLEGES THAT A PATIENT WHO HAD A 2 LEVEL ACDF (C4-C6) HAD AN EARLY SCREW FRACTURE. THE ORIGINAL IMPLANTATION DATE WAS (B)(6) 2017 AND CORELINK WAS NOTIFIED OF THE ALLEGED FRACTURE ON (B)(6) 2017. THE FRACTURE WAS DISCOVERED DURING THE PATIENTS POST-SURGERY FOLLOW-UP. THE USER IDENTIFIES THE PATIENT TO BE A "LARGER WOMAN", (B)(6) (NO EXACT WEIGHT OR DATE OF BIRTH WAS PROVIDED). THE ALLEGED SCREW FRACTURE TOOK PLACE AT THE C6 LEVEL. THE SCREW UTILIZED WAS A 4.5MM X 18MM FIXED ANGLE SELF TAPPING SCREW (20445-18) USED IN CONJUNCTION WITH 5 OTHER SCREWS AND A 30MM 2 LEVEL PLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6695371 ↗
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- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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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