N/A 5484821Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994609823), received between Apr 12, 2022 and Mar 6, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS 4/5. IT WAS REPORTED THAT THE TIP OF THE SCREW DRIVER IS BROKEN AND IS STILL IN THE SET SCREW, WILL NOT BE REMOVED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE SURGEON IS AWARE OF THE EVENT AND THERE IS NO PLANNED SURGERY. IT IS LOCKED IN SCREW HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531667 ↗
• MalfunctionFeb 8, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. NO FRAGMENTS OF EITHER INSTRUMENT REMAINED IN THE PATIENT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288631 ↗
• MalfunctionNov 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING T3 TO PELVIS FUSION PROCEDURE. IT WAS REPORTED THAT THE HEADS/THREADS OF THE DRIVERS SNAPPED WHILE WORKING ON SCREW WITHIN A PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475946 ↗
• MalfunctionNov 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING T3 TO PELVIS FUSION PROCEDURE. IT WAS REPORTED THAT THE HEADS/THREADS OF THE DRIVERS SNAPPED WHILE WORKING ON SCREW WITHIN A PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475941 ↗
• MalfunctionAug 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF A DRIVER WAS FOUND SHEERED OFF WHILE GOING THROUGH AN EXTRA SET. 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 22724665 ↗
• MalfunctionJul 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T6-10 POSTERIOR SPINAL FUSION AND DECOMPRESSION PROCEDURE IN A PATIENT DIAGNOSED WITH DEGEN PSF. IT WAS REPORTED THAT SURGEON WAS ATTEMPTING TO TIGHTEN THE SET SCREW ON A CONNECTOR AND TIGHTENED IT TOO TIGHT AND THE TIP SHEARED OFF INTO THE CAP. SURGEON WAS ABLE TO RETRIEVE THE TIP WITH NERVE HOOK AND A NEW DRIVER WAS USED. 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 22409807 ↗
• MalfunctionMar 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR INFECTION. PROCEDURE OR THERAPY PERFORMED WAS PEDICLE SCREW REMOVAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS BROKEN. PRODUCT CAME INTO CONTACT WITH SCREW THAT WAS IN A PATIENT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543378 ↗
• MalfunctionFeb 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING OPEN LUMBAR FUSION THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT THE SCREW WAS NOT FULLY INSERTED AND HAD TO BE REMOVED AND REPLACED. ADDITIONALLY, THERE WERE REPEATED INSERTIONS OF PELVIC SCREWS DUE TO THE DRIVERS BREAKING. THE TIPS OF THE DRIVERS SHEARED OFF BEFORE THE SCREW WAS FULLY INSERTED. UNFORTUNATELY THE TIP WAS NOW IN THE SCREW HEAD AND COULD NOT BE ADVANCED SO THE SCREW HAD TO REMOVED AND REPLACED WITH A NEW ONE. THE PLIERS DIDN'T WORK AND THE SPRING WAS JACKED UP. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419324 ↗
• MalfunctionApr 29, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR STENOSIS. PROCEDURE OR TECHNIQUE USED WAS TL REVISION. IT WAS REPORTED THAT THE SCREWDRIVERS WERE BROKEN. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199634 ↗
• MalfunctionApr 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT FUSION S PINAL THERAPY FOR L3-4 STENOSIS AND L4-5 REMOVAL OF HARDWARE. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE SET SCREWS, THE DRIVERS BROKE OFF. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS WERE USED IN SAME EVENT. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083363 ↗