NA 03.661.125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034721217), received between May 26, 2017 and Jun 13, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF A TEMPORARY FIXATION PIN-LONG, THE THREADED TIP BROKE OFF THE SHAFT OF THE INSTRUMENT. IT WAS REMOVED USING A BITING RONGEUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF THREE (3) MINUTES DUE TO THE REMOVAL OF A BROKEN TIP. FRAGMENTS WERE EASILY REMOVED. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695994 ↗
• InjuryMay 26, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN L5-S1 ALIF (ANTERIOR LUMBAR INTERBODY FUSION) PROCEDURE, USING THE ANTEGRA SYSTEM, THE LONG TEMPORARY FIXATION PIN BROKE OFF IN THE BONE. THE SURGEON WAS REMOVING THE TEMPORARY FIXATION PIN FROM THE 4TH AND FINAL HOLE OF THE 4-HOLE ANTEGRA PLATE IN PREPARATION OF PLACING THE LAST SCREW WHEN THE PIN BROKE. THE DISTAL PORTION OF THE PIN REMAINS EMBEDDED. THE PROXIMAL PORTION OF THE PIN WILL BE RETURNED. THE SURGEON COMPLETED THE PROCEDURE WITHOUT PLACING A 4TH SCREW. THERE WAS NO REPORTED SURGICAL DELAY, AND THE PATIENT WAS REPORTEDLY STABLE. THERE IS ONE DEVICE ON THIS COMPLAINT. THERE IS 1 DEVICE IN THIS COMPLAINT CONCOMITANT PART REPORTED: ANTEGRA 4-HOLE PLATE (QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6594432 ↗