Mecta-C Cervical Plate System 03.70.279Recalls & reported problems
Medacta International SA · Fixed self-tapping screw diam. 4x18mm (2x) · Class 2 · Implant
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 07630030841361), received between Sep 15, 2021 and Sep 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity 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.
MalfunctionSep 15, 2021Material Integrity Problem; Material Integrity Problem
AT 3 MONTHS AFTER THE PRIMARY SURGERY, THE C7 SCREW ON THE RIGHT SIDE IS BROKEN, AND ADDITIONALLY, IT IS SUSPECTED THAT THE SCREW ON THE LEFT SIDE IS LOOSE. THE PATIENT WAS IN AN ASYMPTOMATIC CONDITION, THEREFORE NO REVISION SURGERY WAS PLANNED INITIALLY. ONE MONTH AFTER, OTHER SCREWS HAD BROKEN (IN C6 LEVEL). ON (B)(6) 2021, 4 MONTHS AFTER THE PRIMARY SURGERY, ADDITIONAL SURGERY WAS PERFORMED. IN TOTAL, FOUR SCREWS WERE FOUND BROKEN (C6 AND C7 LEVELS ON BOTH SIDES). NO IMPLANTS HAVE BEEN REVISED AS THE PATIENT WAS IN AN ASYMPTOMATIC CONDITION. TO STOP ADDITIONAL SCREW LOOSENING OR BREAKING, A 360° FIXATION WAS TAKEN.
Patient problems: Failure of Implant
MAUDE report 12473832 ↗
Other Appliance, Fixation, Spinal Intervertebral Body devices
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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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