N/A 5480004VRecalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00613994429742), received between Jul 17, 2018 and Sep 15, 2026 — classified as 2 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Break” (112 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Transforaminal Lumbar Interbody Fusion. It was reported that the tip of the driver is broken. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received from the manufacturer representative stating that the broken piece was discarded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766741 ↗
• MalfunctionSep 9, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Posterior Fixat ion. It was reported that the tip of the driver broke. 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 50686996 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546480 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540905 ↗
• MalfunctionAug 26, 2026Material Deformation

  Information was received from user facility via a manufacturer representative regarding a device used for Spinal therapy. It was rep orted that a driver was found to be stripped and another T-25 driver broke. There was no patient involved. Additional information received that the T25 driver is stripped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446258 ↗
• MalfunctionJul 27, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50032144 ↗
• MalfunctionMay 29, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL REVISION SURGERY AT THE PELVIS LEVEL, A T-25 SCREWDRIVER TIP BROKE INSIDE THE SCREW SHAFT WHILE THE SCREW WAS BEING TIGHTENED. THE BROKEN TIP WAS REMOVED FROM THE PATIENT, WITH NO FRAGMENT REMAINING. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WAS DELAY OF 45 MINUTES IN OVERALL PROCEDURE TIME FOR GETTING THE BROKEN TIP OUT. PATIENT HAD SURGERY 10 YEARS AGO L3/L5, FURTHER SURGERY TO EXTEND THE CONSTRUCT TO PELVIS WAS SCHEDULED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331593 ↗
• MalfunctionMay 4, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS 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 25066851 ↗
• MalfunctionApr 3, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR POSTERIOR SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENTS WERE MISSING FROM TWO BALL-ENDED DRIVERS. ADDITIONALLY, A BALL-ENDED REMOVAL DRIVER, A BONE SCREW EXTRACTOR AND A FLEXIBLE ARM INSTRUMENT BROKE DURING A PSF PROCEDURE, WITH CONFIRMATION THAT NO FRAGMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776654 ↗
• MalfunctionApr 2, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING T11-PELVIS SCREW REMOVAL FROM PREVIOUS FUSION THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE TIP OF THE DRIVER SNAPPED OFF DURING SCREW REMOVAL. TORX SHAFT WAS STRIPPED AND NOT WORKING EFFECTIVELY. THIS REVISION SURGERY HAPPENED DUE TO PROGRESSION OF PATIENT'S CONDITION. 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 24766512 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566670 ↗
• MalfunctionMar 10, 2026Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WEAR AND TEAR ISSUE OBSERVED FOR ALL THE INSTRUMENTS. 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 24554948 ↗
• MalfunctionJan 23, 2026Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT DURING ROUTINE INSTRUMENT INSPECTION, THE INSTRUMENTS WERE AS WORN BEYOND USABLE SPECIFICATIONS. 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 24159074 ↗
• MalfunctionJan 23, 2026Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT DURING ROUTINE INSTRUMENT INSPECTION, THE INSTRUMENTS WERE AS WORN BEYOND USABLE SPECIFICATIONS. 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 24159068 ↗
• MalfunctionJan 19, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT SCREWDRIVER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108647 ↗
• MalfunctionJan 15, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR POSTERIOR FIXA TION PROCEDURE. IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN AND PRODUCT WAS USED BEFORE. 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 24077734 ↗
• MalfunctionDec 24, 2025Break; Break

  INFORMATION WAS RECEIVE FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. NO PATIENT WAS INVOLVED IN HIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887154 ↗
• MalfunctionDec 24, 2025Break; Break

  INFORMATION WAS RECEIVE FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. NO PATIENT WAS INVOLVED IN HIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887151 ↗
• MalfunctionDec 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A USED IN A SPINE SURGERY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT IT OCCURRED INTRA-OP, NO FRAGMENTS WERE LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886008 ↗
• MalfunctionDec 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A USED IN A SPINE SURGERY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT IT OCCURRED INTRA-OP, NO FRAGMENTS WERE LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885905 ↗
• MalfunctionNov 13, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DRIVER TIP WAS STRIPPED. 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 23539910 ↗
• MalfunctionOct 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVER WAS BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345554 ↗
• MalfunctionOct 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED IN POSTERIOR LUMB AR. IT WAS REPORTED THAT THE DRIVERS AND THE OBTURATOR WERE BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345133 ↗
• MalfunctionSep 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT DURING CLEAN UP IT WAS NOTICED THAT THE TIP OF INSTRUMENT BROKE OFF. 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 23060100 ↗
• MalfunctionSep 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF -TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT BALL TIP IS BROKEN. 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 23001583 ↗