NA 389.873Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034777238), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 injury.

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. 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.

• InjuryNov 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF). THE FIXATION PIN WAS USED TO TEMPORARY FIX THE ANTERIOR TENSION BAND (ATB) PLATE TO THE CORRECT POSITION. AFTER HAVING FIXED THE FIRST THREE SCREWS, DURING REMOVAL OF THE FOURTH FIXATION PIN THE TIP BROKE OFF. TIP WAS LEFT IN PLACE AND THE FINAL SCREW WAS INSERTED. THE FINAL SCREW WAS SMALLER THAN THE REMAINING SCREWS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICE REPORTED: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3), ATB PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DETACHABLE TEMPORARY FIXATION PIN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8102699 ↗