N/A 5484823Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994803092), received between Nov 30, 2021 and Apr 17, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER BROKE WHILE THE SURGEON WAS ADVANCING SCREWS DUE TO VERY SCLEROTIC BONE. IT WAS CONFIRMED THAT NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS, OR ADDITIONAL TREATMENTS OR SURGERIES REQUIRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854661 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1/2/3 TRANSFER AMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY OF L3/4 PLF ON (B)(6) 2012 AND PRESENTED ADJACENT INTERVERTEBRAL DISORDER. THE REVISION SURGERY WAS PERFORMED AS A RESULT OF THE EVENT. DURING AN ATTEMPT TO REMOVE L3/4, WH ILE TRYING TO REMOVE THE SET SCREW ON THE RIGHT SIDE OF L4 USING OBTURATOR, THE TIP BROKE. THE BROKEN TIP WAS REMOVED, AND AN ATTEMPT WAS MADE TO EXTRACT IT USING THE RETAINING BONE SCREWDRIVER, BUT ITS TIP ALSO BROKE. AS THE TIP COULD NOT BE REMOVED FROM THE SET SCREW, THE SET SCREW WAS GROUND DOWN WITH A STEEL BAR, AND THE ROD WAS REMOVED. SCREWS ATL3 AND L4 WERE REMOVED, AND NEW SCREWS WERE INSERTED AT L1, L2, AND L3. L3, 4 SCREWS WERE REMOVED AND NEW SCREWS WERE INSERTED INTO L1, 2 AND 3. THERE WAS A DELAY IN OVERALL PROCEDURE TIME. 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 21443661 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442452 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442450 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREWDRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442443 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442439 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442437 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442434 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442432 ↗
• MalfunctionFeb 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED IN TLIF FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE TIP BROKE OFF OF A THREADED DRIVER WHEN DRIVING A PEDICLE SCREW IN A PATIENT WITH EXTREMELY HARD SCLEROTIC BONE. TIP WAS RETRIEVED AND ANOTHER DRIVER WAS USED SUCCESSFULLY. NO PATIENT SYMPTOMS WERE REPORTED. NO FRAGMENT WAS REMAINING IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417918 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREWDRIVER USED IN AP LUMBAR F USION THERAPY FOR STENOSIS. LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT THE DRIVER BROKE WHILE TRYING TO ADVANCE THE SCREW. A FRAGMENT OF THE INSTRUMENT IS REMAINING IN THE PATIENT - TIP OF THE DRIVER IS IN THE SCREW. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE NO SYMPTOMS OR COMPLICATIONS THAT WERE CAUSED BY THIS EVENT. THERE WERE ALSO NO EXTRA PROCEDURES OR EXTEND HOSPITAL STAY THAT WERE CAUSED BY THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21362237 ↗
• MalfunctionJan 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER BROKE WHILE THE SURGEON WAS ADVANCING SCREWS DUE TO VERY SCLEROTIC BONE. IT WAS CONFIRMED THAT NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS, OR ADDITIONAL TREATMENTS OR SURGERIES REQUIRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252348 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN THORACOLUMBAR SCREW, ROD AND CAGE INSERTION. IT WAS REPORTED THAT THE DEVICES BROKE. HIGH USE INSTRUMENTS BREAK MORE OFTEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237141 ↗
• MalfunctionDec 31, 2024Break; Break

  INFORMATION WAS WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046717 ↗
• MalfunctionJul 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR MINIMALLY INVASIVE SURGERY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. 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 19789656 ↗
• MalfunctionJul 2, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS TRYING TO TAKE OUT AN IMPLANTED SCREW TO MOVE AND INSTRUMENTS STRIPPED, SURGEON WAS TRYING TO READJUST A SCREW AND THE TIPS BROKE OFF. NO FRAGMENT OF THE INSTRUMENT WAS REMAINING IN THE PATIENT.  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 19653890 ↗
• MalfunctionJul 2, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS TRYING TO TAKE OUT AN IMPLANTED SCREW TO MOVE AND INSTRUMENTS STRIPPED, SURGEON WAS TRYING TO READJUST A SCREW AND THE TIPS BROKE OFF. NO FRAGMENT OF THE INSTRUMENT WAS REMAINING IN THE PATIENT.  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 19653860 ↗
• MalfunctionNov 30, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4/5 PRONE POSITION TLIF IN A PATIENT DIAGNOSED WITH DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT ONE OF THE DRIVERS BROKE, THE OTHER IS DAMAGED/STRIPPED. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889125 ↗