CETRA 19-6516Recalls & reported problems
Orthofix US LLC · 4.0mm X 16mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18257200134946), received between Sep 18, 2024 and Sep 18, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WENT IN FOR A 6 WEEK FOLLOW UP. PATIENT HARDWARE WAS INTACT. AT 4 MONTHS A LOCKING MECHANISM FAILED. TWO INFERIOR SCREWS AND FAILED LOCKING MECHANISM WERE REMOVED AND DISCARDED PER BANNER HOSPITAL POLICY. DEVICE NOT RETURNING. A REVISION WAS PERFORMED ON (B)(6) 2024. NO KNOWN NON-UNION. NO ISSUES INTRAOPERATIVELY. PATIENT HAD NO FALL OR ANY ACCUTE INJURY.
Patient problems: Failure of Implant
MAUDE report 20250824 ↗InjurySep 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WENT IN FOR A 6 WEEK FOLLOW UP. PATIENT HARDWARE WAS INTACT. AT 4 MONTHS A LOCKING MECHANISM FAILED. TWO INFERIOR SCREWS AND FAILED LOCKING MECHANISM WERE REMOVED AND DISCARDED PER BANNER HOSPITAL POLICY. DEVICE NOT RETURNING. A REVISION WAS PERFORMED ON (B)(6)2024. NO KNOWN NON-UNION. NO ISSUES INTRAOPERATIVELY. PATIENT HAD NO FALL OR ANY ACCUTE INJURY. REV. 1 CORRECT COMPONENT CODE TO 568 SCREWS.
Patient problems: Failure of Implant
MAUDE report 20249342 ↗
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- Elegance® Anterior Cervical Plate 53430112Clariance · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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