NA 389.872Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034777221), received between Aug 22, 2018 and Aug 22, 2018 — 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 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.

• MalfunctionAug 22, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING L5/S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SURGERY, THE DRIVER FOR DETACHABLE TEMPORARY FIXATION PIN BROKE WHILE REMOVING FIXATION PIN FROM PATIENT. THE SURGEON USED FORCEPS TO REMOVE BROKEN TABS. THERE WAS FIVE (5) MINUTE OF SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN FIXATION PIN (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) DRIVER FOR DETACHABLE TEMPORARY FIXATION PIN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806810 ↗