NA 324.043Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982191021), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE THERE WAS A WEAR AND TEAR OF FIXATION BOLT FOR LESS INVASIVE STABILIZATION SYSTEM (LISS) INSERTION GUIDE AND THE LISS INSERTION GUIDE WAS ALSO UNABLE TO BE FULLY SECURED DUE TO INABILITY TO TIGHTEN SUCCESSFULLY DUE TO STRIPPING DURING TIGHTENING. THERE WAS A TWENTY (20) MINUTES OF SURGICAL DELAY AS SURGEON HAD TO DO A LONGER INCISION FOR A VERY LONG PLATE INSTEAD OF USING A MINIMAL INVASIVE JIG. PATIENT OUTCOME IS REPORTED AS LONGER INCISION TO RECOVER FROM. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) FIXATION BOLT FOR LISS INSERTION GUIDES THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11674755 ↗