N/A 897-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00673978956541), received between Dec 19, 2023 and Jul 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR LUMBAR INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT A RESTERILIZABLE PIN WAS FOUND BROKEN IN THE STERILE BOX. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528484 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) L5/S1 SPINAL THERAPY. IT WAS REPORTED THAT THE DISTAL PART OF THE PIN WAS BROKEN INSIDE THE VERTEBRA AND LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED FOR REMOVAL AS IT IS IMPOSSIBLE TO EXTRACT THE BROKEN FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21362342 ↗
• MalfunctionDec 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR LUMBOT OMY L5-S1 FOR LUMBAR ANTHERODESIS. IT WAS REPORTED THAT DURING THE INTERVENTION, THE SPINDLE SCREWED INTO THE BODY OF L5 BROKE AT ITS DISTAL END WITH AN INTRAOSSEOUS BREAK LEFT IN PLACE BECAUSE IT WAS NOT AGGRESSIVE. A 14 MM HIGH ROI A (LDR) CAGE WAS INSTALLED. PATIENT CURRENTLY HAS A PERSISTENT INTRAOSSEOUS METALLIC FRACTURE AT L5. NO INTRAOPERATIVE COMPLICATIONS WITH GOOD RESTORATION OF LORDOSIS.THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18396643 ↗
• InjuryDec 19, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ALIF SURGERY FOR PLACEMENT FOR SOVEREIGN CGAE. IT WAS REPORTED THAT STABILITY PIN WAS BROKEN. PIN WAS LEFT IN PLACE HAD TO BE REMOVED DURING A SECOND OPERATION ON THE SAME DAY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18353721 ↗