NA 03.632.081Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034719245), received between Feb 28, 2018 and Feb 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 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.

• MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGERY FOR L4 LIMBUS VERTEBRA WAS PERFORMED BY USING THE MATRIX 5.5 SYSTEM. THE FIXED AREA WAS T10 ¿ L4. WHEN THE INSTRUMENT WAS CHECKED ON (B)(6) 2018, IT WAS FELT THAT THE RATCHET FOR THE ROD FOLDER HAS MUCH PLAY AND WAS EASILY DETACHED. THE SURGEON POINTED OUT THAT THIS ISSUE HAPPENED DURING THE OPERATION ON (B)(6) 2018. THE SURGERY WAS COMPLETED WITH NO DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303520 ↗