N/A 8350312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994282835), received between Nov 13, 2025 and Mar 10, 2026 — classified as 4 malfunctions.

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 16, 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.

• MalfunctionMar 10, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION (L5-S) DUE TO SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE ROD HOLDER SUDDENLY BROKE DURING NORMAL USE. AS NO UNUSUAL HANDLING WAS INVOLVED, IT IS CONSIDERED THAT THE BREAKAGE MAY HAVE BEEN DUE TO AGING DETERIORATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559667 ↗
• MalfunctionJan 21, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ROD REPLACEMENT SPINAL THERAPY FOR ROD FRACTURE. LEVELS INVOLVED WAS L2/S2. INITIAL SURGERY HAPPENED ON (B)(6) 2023 FOR INSTITUTE FIXATION WITH OPENNESS FOR DISH/REVERSE CHANCE FRACTURE. LEVELS INVOLVED WAS L2/S2. IT WAS REPORTED THAT THE REVISION SURGERY HAPPENING BECAUSE A PATIENT WHO HAD FIXATION AT L2/S2 UNDERWENT A REOPERATION TO REPLACE THE ROD DUE TO ROD FRACTURE AT L4/5. THE FRACTURED ROD WAS REMOVED, AND A NEW ROD WAS INSTALLED. DURING THIS PROCESS, THE ROD WAS HELD USING THE CORRESPONDING ROD HOLDER IN ORDER TO ROTATE IT. AFTER THE ROD WAS INSTALLED, THE ROD HOLDER WAS REMOVED FROM THE SURGICAL FIELD AND WAS FOUND TO BE DAMAGED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128207 ↗
• MalfunctionNov 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING R EVISION SURGERY TO REMOVE NAIL AFTER BONE FUSION AFTER INITIAL PROCEDURE ON (B)(6) 2024. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE ROD, IT WAS DIFFICULT TO EXTRACT. WHILE APPLYING SLIGHT TWISTING AND PULLING, THE ROD HOLDER FRACTURED. REVISION SURGERY WAS NOT DUE TO MEDTRONIC PRODUCT MALFUNCTION. THE REMOVAL OF SCREWS AFTER BONE UNION, WHICH WAS ORIGINALLY SCHEDULED. THERE WAS A DELAY OF LESS THAN 60 MINS. 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 23645672 ↗
• MalfunctionNov 13, 2025Crack; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL CORRECTION AND FUSION THERAPY AT T4-L1 FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT DURING THE CORRECTION OPERATION, A BEEP SOUND WAS HEARD, AND THE SURGEON LATER OBSERVED THAT THE ROD HOLDER PLACED ON THE MOST CRANIAL SIDE OF THE ROD HAD CRACKED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541968 ↗