N/A 897-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978956558), received between Jun 26, 2018 and Feb 25, 2025 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING STABILITY PIN USED IN ANTERIOR LUMBAR INTERBODY FUSION (ALIF). IT WAS REPORTED THAT THE DISTAL PART OF THE STABILITY PIN BROKE INSIDE THE BONE. SO THERE WAS FRAGMENTS OF INSTRUMENT INSIDE THE PATIENT. LEVELS IMPLANTED WAS L5/S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE FOUND OUT TO BE SPONDYLOSTESIS AT L5/S1. NO ADVERSE EVENT REPORTED TO PATIENT. THERE IS NO REVISION SURGERY PLANNED/ OCCURRED TO REMOVE THE FRAGMENTS OF THE INSTRUMENT FROM THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21456793 ↗
• InjuryJun 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SURGERY. INTRA-OP, TIP OF THE PIN BROKE AND REMAINED IN THE VERTEBRA BODY. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN. NO REVISION SURGERY HAS BEEN PERFORMED/PLANNED TO REMOVE THE FRAGMENTS REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7636655 ↗