N/A 5484336Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994946591), received between Nov 6, 2019 and Nov 7, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (TRANSFORA MINAL LUMBAR INTERBODY FUSION) PROCEDURE TO REMOVE AND REPLACE PREVIOUS HARDWARE AT SPINAL LEVELS T10-S2, WITH PRE-OPERATIVE DIAGNOSES OF INFECTION AND STENOSIS IT WAS REPORTED THAT THE TIP OF A BREAKOFF DRIVER INSTRUMENT BROKE OFF INSIDE THE SET CAP. THE TIP OF THE BREAKOFF DRIVER REMAINED INSIDE THE SET SCREW. FINAL TIGHTENING WAS ACHIEVED USING A DIFFERENT TOOL. IT WAS CONFIRMED THAT A FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THE PRODUCT WAS UTILIZED ACCORDING TO THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23494545 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING DRIVERS USED IN A TLIF. IT WAS REPORTED THAT THE DRIVER TIPS BROKE OFF. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273359 ↗
• MalfunctionJan 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR LUMBAR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS 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 21236308 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING DEVICE MAINTENANCE. IT WAS REPORTED THAT THE DRIVERS BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187805 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING DEVICE MAINTENANCE. IT WAS REPORTED THAT THE DRIVERS BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187804 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4/5 TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN AT THE TIME OF THE FINAL TIGHTENING OF THE REDUCTION SET SCREW. NO FRAGMENTS LEFT IN THE PATIENT. 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 21187757 ↗
• MalfunctionOct 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 OPEN TRANSFORAMINAL INTERBODY LUMBAR FUSION (TLIF) AND FUSION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR RADICULOPATHY. IT WAS REPORTED THAT THE DRIVER HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. LEVELS IMPLANTED WERE L4 L5 S1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365907 ↗
• MalfunctionMay 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING L5-S1 DECOMPR ESSION AT L5 LEVEL WITH EXPANDABLE TLIF DEVICE WITH PEDICLE SCREW FIXATION L5-S1 FOR L5-S1 SPONDYLOTISTHESIS. IT WAS REPORTED THAT AFTER USING REDUCTION TORQUE TOOL TO BREAK OFF FINAL REDUCTION SET SCREW, SURGICAL TECH COULD NOT REMOVE THE APPROPRIATE BROKEN SET SCREW PIECE OFF OF THE DRIVER TIP. AFTER PROPER WASHING AFTER SURGICAL CASE, THE REDUCTION SET SCREW WAS REMOVED AND THE TIP OF THE REDUCTION DRIVER BROKE. ALL FINAL LATERAL AND A/P X-RAYS CONFIRMED NO FRAGMENTS OR PIECES WERE IN PATIENT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266267 ↗
• MalfunctionMay 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF L45. IT WAS REPORTED THAT DURING THE FINAL TIGHTNING OF THE SET SCREWS, THE TIP OF THE DRIVER BROKE OFF. 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 19246120 ↗
• MalfunctionAug 30, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR FUSION. PROCEDURE PERFORMED WAS PLIF L5-S1. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381859 ↗
• MalfunctionMar 4, 2021Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF(LEVELS IMPLANTED-L4/5) DUE TO LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT AT THE TIME OF TLIF AT L4 / 5, WHEN SETTING ON THE LEFT SIDE, THE FINAL TIGHTENING WAS PERFORMED AFTER BREAKING THE INNER TAB OF RMAS. HOWEVER, THE DRIVER TIP WAS BROKEN INSIDE SET SCREW ON THE CONTRALATERAL SIDE AS IT WAS THOUGHT THAT IT WOULD BE OKAY WITHOUT BREAKING THE TAB AND PERFORMING THE FINAL TIGHTENING. THERE WAS PROCEDURAL DELAY OF LESS THAN 60 MINS. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408874 ↗
• MalfunctionOct 1, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER FOR A PLIF (INTRA-OP). IT WAS REPORTED THAT THE DRIVER BROKE AT FINAL TIGHTENING. THE INSTRUMENT BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THE EVENT OCCURRED AT FINAL TIGHTENING OF SCREW ON LEFT L5. THE TAB ON ONE SIDE WAS BROKEN OFF ACCORDING TO IFU, BUT THE TIP OF THE DRIVER BROKE. THE COUNTER TORQUE WAS USED. AFTER THAT, AS A REPLACEMENT, RETAINING SCREWDRIVER WAS USED AND FINAL TIGHTENING WAS ABLE TO BE PERFORMED, AND THE OPERATION WAS ABLE TO BE COMPLETED. THE REPORTED SET SCREW WAS DISCARDED, AND NO DRIVER TIP WAS LEFT IN THE BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS INTERVERTEBRAL DISC HERNIATION AND LEVELS IMPLANTED WERE L5/S. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, SPONTANEOUS PNEUMOTHORAX. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10611916 ↗
• MalfunctionAug 21, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF(TRANSFORAMINAL LUMBAR INTERBODY FUSION) ON L4/5 AND PLIF(POSTERIOR LUMBAR INTERBODY FUSION) ON L5/S1 DUE TO L4 SPONDYLOLISTHESIS, L5 ISTHMIC SPONDYLOLISTHESIS, LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT REDUCTION SET SCREW WAS INSERTED, ROD WAS PLACED, REDUCTION OPERATION WAS PERFORMED WITH DRIVER, WHEN THE FINAL TIGHTENING WAS PERFORMED, FORCE WAS APPLIED AS IT WAS AND THE TIP OF THE DRIVER BROKE. THE BROKEN TIP REMAINED ON SET SCREW BEFORE PERFORMING THE BREAK-OFF FOR SET SCREW, SO THE SET SCREW WAS REMOVED BY THE PLIERS OF HOSPITAL, AND IT WAS REPLACED WITH A NEW SET SCREW, THE FINAL TIGHTENING WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS AN OVERALL PROCEDURE DELAY OF LESS THAN 60 MINS. THE PRODUCT WAS REPLACED AND WILL BE RETURNED. THERE WAS NO FRAGMENT REMAINED IN THE PATIENT¿S BODY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10435631 ↗
• MalfunctionJul 21, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION THERAPY. IT WAS REPORTED THAT THE TIP OF THIS INSTRUMENT BROKE OFF DURING FINAL TIGHTENING. IT WAS STUCK IN THE SET SCREW - NO FOREIGN OBJECTS REMAINED IN THE PATIENT. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10300167 ↗
• MalfunctionDec 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-S2. INTRA-OP, THE DRIVER BROKE WHILE BREAKING OFF THE SET SCREWS. NO FRAGMENT OF THE BROKEN DRIVER REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434869 ↗
• MalfunctionDec 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-S2. INTRA-OP, THE DRIVER BROKE WHILE BREAKING OFF THE SET SCREWS. NO FRAGMENT OF THE BROKEN DRIVER REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434868 ↗
• MalfunctionDec 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-S2. INTRA-OP, THE DRIVER BROKE WHILE BREAKING OFF THE SET SCREWS. NO FRAGMENT OF THE BROKEN DRIVER REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434863 ↗
• MalfunctionNov 6, 2019Break; Break

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9283885 ↗