CERES 12-33-4016Recalls & reported problems
Spinal Elements · Ceres® Self Tapping Variable Screw Ø 4.0x16mm · Class 2 · Implant
Data updated Oct 13, 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 00840916127992), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Fracture; Mechanical Problem
ON (B)(6) 2025, PATIENT UNDERWENT A TWO LEVEL ACDF PROCEDURE (C5-C7). DURING ROUTINE 12 MONTH FOLLOW UP IT WAS REPORTED THAT THE C7 BONE SCREWS HAD FRACTURED. PATIENT IS ASYMPTOMATIC CURRENTLY, WITH NO PLAN FOR REVISION SURGERY AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 24694455 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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