NA 03.616.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034716305), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 malfunction.

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 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.

• MalfunctionNov 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT PERFORMING A MATRIX MIS TIME THE NURSE WAS HAVING DIFFICULTIES TO LOADING A SCREW ONTO THE RETRACTOR TISSUE (LONG). ALSO, DURING THE FINAL TIGHTENING OF THE HANDLE TORQUE LIMITING WAS MAKING A WEIRD NOISE AND SURGEON REQUESTED TO REPLACE THE HANDLE. THE PATIENT WAS NOT IMPACTED BY THIS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR 1 (B)(4). .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9312046 ↗