N/A 7578195Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994565761), received between Jun 23, 2020 and Sep 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for Transforaminal Lumbar Interbody Fusion. It was reported that the set screw and the lock won't fix. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as there was no issue with the set screw.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941844 ↗
• MalfunctionFeb 9, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR TRANSF ORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE SET SCREW WAS NOT FIXED. 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 24289370 ↗
• MalfunctionOct 22, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT THE INSTRUMENT WAS NOT ABLE TO FIX THE ROD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355457 ↗
• MalfunctionAug 8, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A COMPRESSOR TO BE USED IN A TLIF. IT WAS REPORTED THAT THE COMPRESSOR CANNOT HOLD THE SET SCREW AND CANNOT BE SEPARATED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939766 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A COMPRESSOR USED FOR TLIF. IT WAS REPORTED THAT THE INSTRUMENT COULD NOT BE ASSEMBLED AFTER DISASSEMBLY. 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 19266186 ↗
• MalfunctionJun 23, 2020Break; Break

  PRE-OP DIAGNOSIS - ADJACENT SEGMENT DISEASE. LEVELS IMPLANTED - L4/5 PROCEDURE PERFORMED: PERCUTANEOUS POSTEROLATERAL INTERBODY FUSION (MIS-TLIF) INTRA OP, TIP OF THE INSTRUMENT BROKE OFF. AFTER THE FINAL TIGHTENING OF THE SET SCREW, THE NEXT SET SCREW COULD NOT BE GRIPPED WELL. WHEN THE TIP WAS CHECKED, IT WAS FOUND THAT THE VANE WAS MISSING ON ONE SIDE. NO FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10182866 ↗