Mecta-C Cervical Plate System 03.70.018Recalls & reported problems
Medacta International SA · Variable self-drilling screw diam. 4x16mm (2x) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030840029), received between Aug 2, 2017 and Feb 10, 2022 — classified as 2 malfunctions.
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
- Detachment Of Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2022Break; Break
DURING THE 3-LEVEL ACDF (FROM 4 TO 7) PROCEDURE WHEN THE SURGEON WAS IMPLANTING THE SCREWS, ONE SCREW BROKE DURING IMPLANTATION. THE SURGEON THEN PROCEEDED TO IMPLANT ANOTHER SCREW WHICH ALSO BROKE. THE AGENT PROVIDED THE SURGEON WITH A SCREW REMOVAL KIT AND THE SURGEON WAS ABLE TO REMOVE ONE OF THE SCREWS AND IMPLANT A NEW ONE IN ITS PLACE. THE OTHER SCREW (ON C4) REMAINED AS THE SURGEON WAS NOT ABLE TO REMOVE IT. THERE WAS A 40-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A LOANER SET WAS UTILIZED. THE PATIENT HAD A HARD BONE. ADDITIONAL ANESTHESIA WAS ADMINISTERED. TOTAL SURGERY TIME 2 HOURS 45 MINUTES.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13505837 ↗MalfunctionAug 2, 2017Break; Detachment Of Device Component
A SCREW OF THE CERVICAL PLATE SYSTEM WAS BROKE OFF DURING SURGERY. IT WAS REMOVED AND SUBSTITUTE WITH A NEW SCREW, COMPLETING THE SURGERY. THE DELAY WAS ABOUT 5 MIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6760044 ↗
Other Appliance, Fixation, Spinal Intervertebral Body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- 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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