NA 03.815.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034728179), received between Mar 20, 2020 and Jul 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE INNER SHAFT BROKE ON AN INSERTER. ADDITIONALLY, THE BALL TIP PROBES BENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A TRIAL SPACER AND IMPLANT HOLDER FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755872 ↗
• MalfunctionMar 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SPINDLE OR TRIAL INSERTER BECAME LOOSE AND COULDN¿T BE REMOVED POST PROCEDURE WHEN PACKING UP SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862637 ↗