Mecta-C Cervical Plate System 03.70.273Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030841309), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2019Break; Break

  DURING PRIMARY SPINE SURGERY WAS USED A 2 LEVEL PLATE REQUIRING 6 PIECES OF SCREWS. THE SURGEON PREFERRED THE FIXED SELF-DRILLING SCREWS (LENGTH 12MM, 4,0MM DIAM.). ON THE LEANER SET WERE ONLY 2 X 2 PIECES OF THAT SIZE. THEREFORE HE USED THE SELF-TAPPING SCREWS OF THE SAME LENGTH AND DIAMETER. HE USED THEM IN THE SAME MANNER AS THE SELF-DRILLING SCREWS WITHOUT DRILLING AND TAPPING. WHEN THE SCREW HEAD APPROACHED THE PLATE, THE SURGEON WAS NOT FULLY SATISFIED WITH THE PLACEMENT AND TRIED TO CORRECT THE SCREWS BY USING THE SELF-RETAINING SCREWDRIVER NO.03.70.10.0032. THIS WAS ALSO CAUSED BY THE RETRACTOR IN PLACE INFLUENCING THE ANGULATION OF THE SCREW-INSTRUMENT ASSEMBLY AND THE SCREW TRAJECTORY. BY USING THIS INSTRUMENT HE EXERTED MUCH-BENDING FORCES ON THE ONTO THE SELF-RETAINING SCREWDRIVER THAT RESULTED ON SCREW DAMAGE. THE SURGEON REPLACED THE DAMAGED SCREW BY A 4,5MM RECUE SCREW OF 12MM LENGTH AND THE SURGERY WAS SUCCESSFULLY PERFORMED. THE SURGEON WAS SATISFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612048 ↗