Mecta-C Cervical Plate System 03.70.055Recalls & reported problems
Medacta International SA · Variable self-tapping screw diam. 4x14mm (2x) · Class 2 · Implant
Data updated Oct 18, 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 07630030840333), received between Jun 8, 2018 and Aug 17, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Pain2
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2018Break
THE PATIENT CAME IN COMPLAINANT OF PAIN 3 MONTHS AFTER PRIMARY: THE SCREW HAD BROKEN. IT IS UNKNOWN IF THE PATIENT WILL BE REVISED AT ALL. UPDATE JUL 31, 2018 FROM THE AGENT: THE SURGEON IS PLANNING ON REVISING THIS PATIENT BUT IS NOT GOING TO GO ANTERIOR, SURGEON IS GOING TO ELECT TO JUST GO POSTERIOR AND ADD SOME SCREWS AND RODS.
Patient problems: Failure of Implant; Pain
MAUDE report 7793274 ↗InjuryJun 8, 2018Break
THE PATIENT CAME IN COMPLAINING OF LEFT ARM AND NECK PAIN 3 YEARS AND 3 MONTHS AFTER PRIMARY. THE PATIENT HAS PSEUDOARTHROSIS. THE SURGEON REMOVED MEDACTA SCREWS AND 1 PLATE. ONE SCREW COULD HAVE NOT BEEN REMOVED AS THE HEAD WAS FOUND BROKEN DURING REVISION. THE SURGEON WAS ABLE TO RECOVER THE HEAD OF THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 7582505 ↗
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- 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
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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