N/A 8350316Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00613994282873), received between Mar 19, 2020 and May 29, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Break” (47 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Corroded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A COUNTER TORQUE, DRIVER & TURNER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT RUST WAS FOUND IN THE INSTRUMENTS. ALL ITEMS WERE USED MULTIPLE TIMES. 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 25331463 ↗
• MalfunctionApr 21, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT THE HANDLE SHEERED OFF THE SHAFT. 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 24934171 ↗
• MalfunctionApr 15, 2026Break

  INFORMATION RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE BREAKOFF TAB HOLDER HAS BROKEN OFF ON ONE SIDE AT THE TOP, BY THE T-HANDLE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882353 ↗
• MalfunctionJan 5, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS NOT HOLDING SET SCREWS, FALLING OUT REPEATEDLY. 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 23954502 ↗
• MalfunctionDec 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER. IT WAS REPORTED THAT TAB TO HOLD BROKEN SET SCREWS IS BROKEN ON ONE SIDE. 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 23908495 ↗
• MalfunctionDec 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4-S1 TLIF PROCEDURE. IT WAS REPORTED THAT THE DRIVER SHEARED DURING FINAL BREAK OFF PORTION OF THE PROCEDURE. 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 23861941 ↗
• MalfunctionNov 28, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER. IT WAS REPORTED THAT THE DRIVER WON¿T HOLD SET SCREWS. 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 23670216 ↗
• MalfunctionSep 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT MULTIPLE INSTRUMENTS WERE FOUND TO BE BROKEN OR WORN DUE TO NORMAL WEAR AND TEAR. A BROKEN TIP, RATCHETING HANDLE WAS WORN DOWN AND DOES NOT RATCHET, ANGLE POSITIONER DEVICE WAS WORN AND WOULD NOT ENGAGE THE SCREW HEAD, AND AN OBTURATOR THAT WAS STRIPPED AT THE END. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992012 ↗
• MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THIS DRIVER IS DESIGNED TO RETAIN BREAK OFFS INTERNALLY UNTIL CLEARED. THERE'S A PIECE INSIDE THAT HOLDS THE SHEERED BREAK OFFS IN PLACE. THIS PIECE IS MISSING. THEREFORE THIS DRIVER WILL NO LONGER RETAIN SET SCREW BREAK OFFS AND IS THEREFORE UNUSABLE. . 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 22962791 ↗
• MalfunctionAug 11, 2025Component Missing; Component Missing

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING SERVICING. IT WAS REPORTED THAT BREAKOFF RETENTION TABS WERE MISSING FROM THE DEVICE. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768860 ↗
• MalfunctionJun 25, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DRIVER EXPERIENCED A MALFUNCTION AS IT WOULD NOT HOLD BROKEN OFF SET SCREWS. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325649 ↗
• MalfunctionJun 24, 2025Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT T-HANDLE NOT CAPTURING SET SCREWS. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. PROCEDURE USED WAS A DEFORMITY SCOLIOSIS. WHEN FINAL TIGHTENING, THE DRIVER WAS NOT CAPTURING THE BREAK OFF SET SCREWS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317224 ↗
• MalfunctionMay 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER IS STRIPPED AND BROKEN. OCCIPITAL IS MISSING SET SCREW. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE OCCIPUT ROD HAD SET SCREWS, BUT BECAME LOST OVER TIME SO NOT AN INITIAL DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050034 ↗
• MalfunctionFeb 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REP ORTED THAT INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401663 ↗
• MalfunctionFeb 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, RETAINING TAB ON BREAK OFF TOOL, AND ROD TEMPLATE WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372577 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TABS ON THE SIDES OF DRIVER ARE BROKEN OFF. THAT TABS WILL HELP TO RETAIN THE BREAK OFF OF THE SET SCREW. WHICH WAS NOTICED DURING POST-OP BETWEEN CLEANING ON RETRIEVING THE INSTRUMENT. 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 21362755 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING PRODUCTS USED FOR SPINAL THERA PY. IT WAS REPORTED THAT THE TIP OF THE DRIVERS WERE BROKEN AND SHEERED OFF, CAUSING IT TO NOT SEAT PROPERLY IN THE HEAD OF SCREWS. ADDITIONALLY, THE RETAINING CLIPS ON THE TIP BROKE OFF, NO LONGER RETAINING THE OBTURATOR DRIVER. FURTHERMORE, THE PROBE OF THE FEELER WAS BENT AND WOULD NOT RETURN TO NORMAL. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354061 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR SPONDYLOSIS. IT WAS REPORTED THAT, THE DRIVER WAS BROKEN. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS AND COMPLICATIONS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303537 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE BOTH OF BREAK-OFF DRIVERS HAVE THE SAME FAILURE. OVER THE COURSE OF USE OVER MULTIPLE YEARS THE INTERNAL TABS THAT RETAIN THE SET SCREWS INSIDE THE DRIVER SHAFT HAVE BROKEN OFF. THEREFORE, THE DRIVERS DO NOT RETAIN THE BREAK-OFFS APPROPRIATELY. IF THE DRIVER IS TURNED UPSIDE DOWN, THEY WOULD FALL OUT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT SO, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289640 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT AFTER THE SURGERY WAS COMPLETED, THE INSTRUMENT NURSE DISCOVERED THAT THE STOPPER PART OF THE 8350316 SET SCREW BREAK-OFF DRIVER HAD BEEN BROKEN. A BROKEN PART WAS ALSO FOUND NEAR THE INSTRUMENT STAND. 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 21289576 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVER'S TIPS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280966 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVERS TIPS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280963 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE METAL TAB ON TOP OF THE DRIVER WAS BROKEN AND THE INSTRUMENT WAS BROKEN AND WOULD NOT RETAIN BROKEN SET SCREW PIECES. THERE WAS NO PATIENT INVOLVED IN THIS EVENT SO, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280774 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN LUMBAR FUSION. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS/SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SHAFT OF PRODUCT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280760 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING DRIVERS AND A HANDLE IN AN L4-5 TLIF WITH REVISION OF PRIOR HARDWARE (SYNTHESES) FOR AN ADJACENT LEVEL BREAKDOWN, STENOSIS OF LUMBAR 4-5. IT WAS REPORTED THAT WHEN THEY WERE SETTING UP FOR THE CASE, ONE OF THE BACK PRONGS IN THE SECOND DRIVER FELL OUT. THE FIRST DRIVER AND TORX SHAFT BROKE WHILE TRYING TO REMOVE PRIOR SYNTHESES HARDWARE. THE INTERNAL MECHANISM OF THE HANDLE BROKE WHILE FINAL TIGHTENING THE FINAL CONSTRUCT. THE HCP SWITCHED TO BREAK OFF SET CAPS INSTEAD OF THE NON-BREAK TO FINISH THE CASE. 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 21271223 ↗