N/A 5484113Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00613994591203), received between Nov 13, 2018 and May 5, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ALL THE INSTRUMENTS FOUND IN A STORAGE DRAWER LOOKED STRIPPED/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 25076880 ↗
• MalfunctionMay 5, 2026Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ALL THE INSTRUMENTS FOUND IN A STORAGE DRAWER LOOKED STRIPPED/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 25076869 ↗
• MalfunctionMar 30, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (TRANSFORA MINAL LUMBAR INTERBODY FUSION) AND PLIF (POSTERIOR LUMBAR INTERBODY FUSION) IT WAS REPORTED THAT WHILE PREPARING OR FOR SURGERY WE OPENED THE KIT AND NOTICED THE INSTRUMENTS IN THE SET WERE BROKEN. WE HAD TO OPEN THE BACKUP SET FOR THE CASE. IT IS UNKNOWN HOW INSTRUMENTS WERE BROKEN BUT CAUGHT BEFORE CASE STARTED. 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 THERE WAS A FRACTURE SPLIT IN INSTRUMENTS, TIP MISSING FROM END OF SCREWDRIVER AND THESE ITEMS HAVE BEEN USED BEFORE WITH OUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729567 ↗
• MalfunctionDec 31, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION FOR PSEUDO ARTHRODESIS. IT WAS REPORTED THAT THE DRIVER WAS STRIPPED. THE ISSUE WAS A COMPONENT INCOMPATIBILITY WHICH WAS REFERRED TO AS A BREAK. THIS INFORMATION HAS BEEN VERIFIED BY THE PHYSICIAN. 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 23932040 ↗
• 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 23345154 ↗
• MalfunctionOct 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR L3-S1 POSTEROLATERAL SPINAL FUSION (PLF). IT WAS REPORTED THAT THE TIPS OF THE DRIVERS WERE BROKE OFF. IT WAS CONFIRMED THAT NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263278 ↗
• MalfunctionJul 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FIXATION PROCED URE FROM L4 TO S2 FOR L5/S PSEUDOARTHROSIS. IT WAS REPORTED THAT DURING THE FIXATION PROCEDURE FOR THE INITIAL SURGERY (PLIF BETWEEN TWO VERTEBRAE) TO ADDRESS PSEUDOARTHROSIS CAUSED BY A SCREW FRACTURE, THE SCREW ON THE LEFT SIDE AT L4/5/S WAS REMOVED. WHILE ATTEM PTING TO INSERT A NEW SCREW FROM L4 TO S2, THE TIP OF THE DRIVER BROKE. A NEW DRIVER WAS USED, BUT THE SCREW DID NOT MOVE, AND THIS DRIVER ALSO BROKE. THE DAMAGED SCREW WAS ULTIMATELY DESTROYED USING A METAL CUTTER AND REPLACED WITH A DIFFERENT SCREW. THE OVERALL PROCEDURE EXPERIENCED A DELAY OF LESS THAN 60 MINUTES. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THE EVENT. THE ALLEGATION OF THE SCREW WAS, IT BECAME NOT-ROTATING, HENCE IT WAS DESTROYED WITH METAL CUTTER INTENTIONALLY. REGARDING THE INITIAL SURGERY. IT WAS REPORTED THAT A SCREW FROM ANOTHER COMPANY WAS USED, WHICH FRACTURED AND LED TO PSEUDOARTHROSIS. AS A RESULT, REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED SCREW. DURING THIS REVISION SURGERY, WHILE REMOVING THE SCREW FROM THE OTHER COMPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589226 ↗
• MalfunctionMar 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THE EVENT HAPPENED WHILE TRYING TO EXTRACT SET SCREWS AND ANOTHER INSTRUMENT USED TO FINISH THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2024-MAR-13 E1 (REP): ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE WAS A TLIF REVISION. REMOVAL OF L4/5 SCREWS WITH AN L3/4 TLIF AND POSTERIOR INSTRUMENTATION FROM L3-5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613273 ↗
• MalfunctionFeb 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR POSTERIOR SPINAL FUSION (PSF) AT LEVELS L4-S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS POSTERIOR SPINAL FUSION (PSF). IT WAS REPORTED THAT WHILE PLACING THE VOYAGER ILIAC SCREWS, THE NAV DRIVER TIP SNAPPED OFF AND SUBSEQUENT ATTEMPTS TO ADVANCE THE SCREW WITH OTHER DRIVERS AND INSTRUMENTS ALSO RESULTED IN BREAKAGE. AND THE END OF THE HEAD TURNER DRIVER WAS MORPHED. THE SCREW WAS REMOVED AND REPLACED WITH ONE OF A SMALLER DIAMETER. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467602 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENT BROKE. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361947 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A T25 TWISTED DRIVER HAVING POSTERIOR SPINE FUSION THERAPY. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE CASE. EVENT OCCURRED AT BACK TABLE AND WHEN THE PHYSICIAN WAS TIGHTENING A SCREW. THE DRIVER WAS FULLY FUNCTIONAL PRIOR TO THE INCIDENT. 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 21355113 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPINE SURGERY FOR REMOVAL OF HARDWARE. IT WAS REPORTED THAT TIP OF THE INSERTER BROKEN OFF IN THE HEADOF THE SET SCREW. LEVELS IMPLANTED L3-L5. NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT BOTH SCREW DRIVERS BROKE DURING THE REMOVAL OF HARDWARE, PROCEDURE USED IN THIS EVENT WAS ADJACENT L2-3 TLIF FOR REMOVAL OF L3-5 HARDWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302042 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE DAMAGED, BENT , OR STRIPPED OVER TIME FROM REPEATED USE. THIS WAS IDENTIFIED  AT BACK TABLE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE RMAS T HANDLE WAS STRIPPED, THE RING CURETTE WAS BROKEN, THE 15 MM BLADE WAS BENT, THE SHAVER WAS BENT, THE NAV DRIVER WAS BROKEN, THE T25 TWIST DRIVER WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282320 ↗
• MalfunctionJan 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINAL FUSION FOR PSEUDOARTHROSIS. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. 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 21250816 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS 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 21237230 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237068 ↗
• MalfunctionNov 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T10-PELVIS PSF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE DRIVERS BROKE DURING SURGERY. 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 20638875 ↗
• MalfunctionSep 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION SPINAL THERAPY. LEVELS IMPLANTED WAS L4-L5. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS NOTICED TO BE BROKEN AND MISSING BEFORE THE SURGERY STARTED. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279620 ↗
• MalfunctionAug 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR TLIF THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023805 ↗
• MalfunctionJul 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674164 ↗
• MalfunctionJun 26, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY DUE TO ROD FRACTURE. IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS DAMAGED DURING SET SCREW REMOVAL. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. 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 19611944 ↗
• MalfunctionJun 13, 2024Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT WORN FROM NORMAL USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526254 ↗
• MalfunctionMay 17, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 TLIF FOR AN INDICATION OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO ADJUST A PEDICLE SCREW IMPLANTED IN THE PATIENT AND BONE QUALITY WAS DENSE. THE TIP OF THE SCREWDRIVERS BROKE AS IMPLANT WOULD NOT MOVE. THE BROKEN FRAGMENTS WERE REMOVED WITH A SUCTION AND DISPOSE. SURGEON LEFT THE SCREW AS IS AND CONTINUED WITH THE CASE WITH NO FURTHER ISSUES TO THE HARDWARE OR 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 19339166 ↗
• MalfunctionMay 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENTS 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 19309179 ↗
• MalfunctionMay 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A TLIF, THE TIP OF THE T25 DRIVER SHEARED OFF INTO THE HEAD OF A 7.5X50MM SCREW. AFTER EFFORTS TO REMOVE THE PIECE LODGED INTO THE SCREWS SHANK, IT WAS DETERMINED THAT IT NEEDED TO BE REMOVED AND REPLACED ALL TOGETHER TO AVOID FURTHER COMPLICATIONS. SINCE ANOTHER DRIVER COULD NOT BE PLACED INTO THE SCREW BECAUSE OF THE BROKEN TIP BLOCKING THE ENTRANCE, IT WAS OPTED TO USE A 30MM ROD, LOCKED IN BY A SET SCREW TO HELICOPTER IT OUT OF THE VERTEBRAL BODY WITH THE HELP OF THE 4.75 COUNTER TORQUE. THE SCREW WAS REMOVED AND REPLACED BY ANOTHER 7.5X50MM SCREW. IT DID NOT IMPACT PATIENT, AND ALL WENT AS PLANNED FOLLOWING THE INCIDENT. 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 19308313 ↗