N/A 8350294Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994282668), received between Nov 26, 2020 and Apr 4, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT, THE TIP OF THE PROBE WAS STUCK IN THE VERTEBRAL BODY. THE SURGEON DEEMED THERE WAS NO RISK OF LEAVING THE FRAGMENT IN PLACE. THE SURGEON DOES NOT HAVE PLAN TO REMOVE THE BROKEN FRAGMENT. THERE HAVE BEEN NO COMPLICATIONS RESULTED AT THIS POINT FROM THE SURGERY. SURGEON WAS USING THE PROBE TO CREATE A PILOT HOLE FOR A PEDICLE SCREW. WHEN THE SURGEON ROTATED THE PROBE ONCE IT WAS IN, THE TIP SNAPPED OFF. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13996347 ↗
• MalfunctionJan 3, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SCOLIOSIS, DEGENERATION THORACIC AND LUMBAR SPINE. PROCEDURE OR THERAPY PERFORMED WAS OLIF. IT WAS REPORTED THAT THE TIP OF THE THREADED SHAFT BROKE OFF DURING IMPLANTATION OF A CAGE AT THE DISC SPACE OF L3/4 DURING AN OLIF. DURING THE POSTERIOR PORTION OF THE SURGERY, THE TIP OF THE INSTRUMENT BENT. THE CAGE WAS IMPLANTED SUCCESSFULLY. THE TIP OF THE THREADED SHAFT REMAINS INSIDE THE IMPLANT IN THE PATIENT. NOTHING HAPPENED TO THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO ADDITIONAL SURGERY IS PLANNED. THE SHAFT TIP WAS SAFELY SECURED INSIDE THE IMPLANT. THERE WAS NO WAY TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13140383 ↗
• MalfunctionJul 6, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF L4-S1 CORONAL DEFORMITY WITH FORAMENAL STENOSIS IN NEED OF L4-S1 PIF IN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT'S BONE WAS EXTREMELY SCLEROTIC AND OVERGROWN, THEREFORE IT WAS VERY HARD AND REQUIRED ADDITIONAL FORCE TO BE USED FROM THE SURGEON, THE TIP OF THE INSTRUMENT BENT AT THIS POINT. THERE WAS A DELAY OF ABOUT 5 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119671 ↗
• MalfunctionDec 22, 2020Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SCOLIOSIS THERAPY. IT WAS REPORTED THAT THE PROBE TIP WAS BENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11053089 ↗
• InjuryNov 26, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A PROBE FOR A POSTERIOR INSTRUMENTED FUSION. IT WAS REPORTED THAT THE PROBE BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THE PATIENT DID COME IN CONTACT WITH THE REPORTED PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS DEGENERATIVE SPINE. THE LEVELS IMPLANTED WERE L2-L4. THERE WAS TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS THE TIME IT TOOK TO REMOVE THE BROKEN PORTION OF THE INSTRUMENT FROM THE BONE. APPROXIMATELY 1 HOUR. THERE WAS A DELAY OF 60 MINUTES DUE TO THIS. THE PRODUCT WILL BE REPLACED BY A MEDTRONIC PRODUCT IN THE FUTURE. THE PATIENT'S MEDICAL HISTORY INCLUDED PREVIOUS SPINAL SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910264 ↗