n/a 2942016Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994866691), received between Oct 16, 2024 and Jun 30, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LATERAL LUMBAR INTERBODY FUSION SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT WHEN USING THIS TOOL TO TREAT THE INTERVERTEBRAL DISC, A FRACTURE OCCURRED AT THE DISTAL TIP. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM REGULATORY BODY THAT THE SURGERY TIME AND RISK OF INFECTION WAS EXTENDED DUE TO FRACTURED TIP. THE PATIENT UNDERWENT LATERAL ANTERIOR LUMBAR DISCECTOMY WITH BONE GRAFT FUSION AND INTERNAL FIXATION. DURING THE PROCEDURE, WHILE USING A LUMBAR CURETTE, THE TIP OF THE CURETTE FRACTURED AND FELL INTO THE BODY CAVITY. AFTER MORE THAN 20 MINUTES OF EXPLORATION AND REMOVAL, THE FRAGMENT WAS COMPLETELY RETRIEVED. THIS SIGNIFICANTLY PROLONGED THE OPERATION TIME AND INCREASED THE RISK OF INTRAOPERATIVE INFECTION. POSTOPERATIVELY, ANTI-INFECTION TREATMENT WAS STRENGTHENED.

  Patient problems: Unspecified Infection

  MAUDE report 25662323 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881838 ↗
• MalfunctionMar 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A OLIF PROCEDURE. IT WAS REPORTED THAT CURRETTE BROKE ON A WIRE BASKET WHILE IN SPD WASHERS AFTER OLIF CASE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512173 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER FOUND BROKEN ON A MISSING INSTRUMENTS BIN IN SPD. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237210 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF FOR LUMBAR ADJACENT VERTEBRA DISEASE. IT WAS REPORTED THAT CURETTE BROKE. DURING THE SURGICAL IMPLANTATION PROCESS, THE FRONT END OF THE SURGICAL TOOL BROKE AND REMAINED IN THE PATIENT'S BODY. AFTER CAREFUL SEARCH BY THE SURGEON, THE FRONT END OF THE TOOL THAT BROKE INSIDE THE PATIENT'S BODY WAS FINALLY REMOVED AT THE SURGICAL SEGMENT. 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 21237155 ↗
• MalfunctionJan 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A CURETTE AND RONGEUR USED IN AN OLIF. IT WAS REPORTED THAT THE CURETTE AND RONGEUR WERE FOUND BROKEN DURING CLEAN UP AFTER THE CASE. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21226558 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING PRIOR TO USE OF REP ORTED PRODUCT. IT WAS REPORTED THAT, THE INSTRUMENT TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187809 ↗
• MalfunctionOct 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR OBLIQUE LATERAL LUMBAR INTERBODY FUSION. LEVELS IMPLANTED AT L5/S1. IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REMOVE AN ELEVATE CAGE AND THE INSTRUMENTS BROKE/BENT. THERE IS NO PATIENT COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459648 ↗