n/a 6550004Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169754515), received between Jun 21, 2020 and Sep 15, 2026 — classified as 1 injury, 52 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771594 ↗
• MalfunctionMay 6, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPO RTED THAT THE INSTRUMENTS WERE BROKEN AND EXPIRED. 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 25104676 ↗
• MalfunctionApr 13, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5/6/S TLIF (TR ANSFORAMINAL LUMBAR INTERBODY FUSION) IT WAS REPORTED THAT AFTER INSERTION OF THE L6 RIGHT SCREW UNDER MAZOR, ADDITIONAL INSERTION WAS ATTEMPTED MANUALLY USING G170059 (CANNULATED RATCHET HANDLE) + 6555004 (SV56 BALL-END BONE SCREWDRIVER), BUT DID NOT ADVANCE DUE TO BONE SCLEROSIS; THE HANDLE WAS CHANGED TO 836-009 (RATCHET T-HANDLE) AND ADDITIONAL MANUAL INSERTION WAS ATTEMPTED, DURING WHICH THE TIP OF 6555004 (SV56 BALL-END BONE SCREWDRIVER) FRACTURED AND REMAINED INSIDE THE SCREW. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 3 APR 2026, UPDATE RECEIVED: POSTOPERATIVELY, THE PATIENT EXPERIENCED NUMBNESS IN THE RIGHT LOWER EXTREMITY. ACCORDING TO THE OPERATING SURGEON, THIS WAS ATTRIBUTED TO INTERVERTEBRAL FORAMINAL STENOSIS CAUSED BY EXCESSIVE COMPRESSION RELATED TO THE PRIOR PROCEDURE. ON (B)(6) 2026, A REVISION PROCEDURE WAS PERFORMED, WHICH INCLUDED ROD LOOSENING AND REPEAT DECOMPRESSION. ADDITIONAL DECOMPRESSION WAS CARRIED OUT, AND THE ROD WAS RE-SECURED USING NEW SET SCREWS. DURING T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24857409 ↗
• MalfunctionApr 1, 2026Break; Detachment of Device or Device Component

  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 24752249 ↗
• MalfunctionMar 6, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS STRIPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529482 ↗
• MalfunctionFeb 26, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS TLIF AT L5/S1 LEVELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454695 ↗
• MalfunctionFeb 4, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, DRIVER TIP BROKE OFF WHEN TRYING TO REMOVE A SET SCREW. BROKEN PART OF THE TIP WAS REMOVED AND DISCARDED. PROCEDURE PERFORMED WAS LUMBAR FUSION/FIXATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258315 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ALL THE INSTRUMENTS WERE FOUND TO BE BENT. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENTS WAS USED MULTIPLE TIMES BEFORE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158995 ↗
• MalfunctionJan 7, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS STRIPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989525 ↗
• MalfunctionDec 29, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE TIP OF THE DRIVER WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904402 ↗
• MalfunctionNov 26, 2025Break; Break

  (B)(6) 2025 UPDATE RECEIVED PROCEDURE WAS THORACOLUMBAR SPINAL DEFORMITY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654316 ↗
• 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 23263258 ↗
• 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 23263251 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING INSPECTION OF INSTRUMENTS IN STERILE PROCESSING PRIOR TO STERILIZATION, EACH SHOWED SIGNS OF WEAR AND STRIPPING AT THE INSTRUMENT TIP. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024765 ↗
• MalfunctionAug 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L4/5 L4/S1 MINIMALLY INVASIVE POSTEROLATERAL FUSION. IT WAS REPORTED THAT THE DRIVER TIP SHEERED OFF IN TULIP HEAD WHILST TRYING TO ADVANCE SCREW. TIP WAS REMOVED AFTER 15MINUTES OF TRYING. 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 22790898 ↗
• MalfunctionJul 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING THORACOLUMBAR POSTERIOR FIXATION T9-S1 FIXATION AT T9-S1. IT WAS REPORTED THAT DURING THE INSERTION OF V5, THE TIP OF THE DRIVER WAS BROKEN. THE TIP COULD NOT BE RETRIEVED, IT REMAINED IN THE SCREW HOLE AND THE SITE WAS CLOSED AS IS. THERE WERE NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR NO ADDITIONAL/REVISION SURGERY PERFORMED. NO ISSUES AGAINST THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381057 ↗
• MalfunctionMay 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT DRIVER TIP BROKE OFF DURING SCREW ADJUSTMENT. DRIVER TIP BROKE IN A SCREW HEAD. INSTRUMENT WAS ASSESSED AFTER DECONTAMINATION. THE METAL FRAGMENT WAS PULLED OUT. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059264 ↗
• MalfunctionMay 5, 2025Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM A HEALTH CARE FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING DEVICES USED FOR SPINE SURGERY. IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN OUT. 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 21959103 ↗
• MalfunctionApr 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE FOR LUMBAR FUSION. IT WAS REPORTED THAT THE ROD HOLDER AND DRIVER BROKE DURING INTRA OP. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. LEVELS IMPLANTED L5/1. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867081 ↗
• MalfunctionApr 2, 2025Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE INTERBODY FUSION SURGERY L3/4/5/S FOR ADJACENT INTERVERTEBRAL DISORDER AT L2/3. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS DAMAGED WHILE REMOVING THE EXISTING SCREW FOR L3. THE DAMAGED PART WAS EXTRACTED TOGETHER WITH THE SCREW. PATIENT POSITIVE FOR INFECTION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750128 ↗
• MalfunctionMar 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BALL ENDED DRIVER WAS STRIPPED, TORX SHAFT AND BALL ENDED REMOVAL DRIVER WERE 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 21511703 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE UPON FULLY SEATING ROD INTO POLYAXIAL SCREW, THE SET SCREW BEGAN TO STRIP AND WAS UNABLE TO ENGAGE THE POLYAXIAL HEAD. ADDITIONALLY, WHEN SURGEON PLACED BALL ENDED DRIVER INTO THE SHANK OF THE SCREW AND ATTEMPTED TO ADVANCE THE SCREW. THE SCREW WAS UNABLE TO BE ADVANCED THE BALL-ENDED DRIVER AS TIP SHEARED OFF, LEAVING THE TIP INSIDE THE SCREW SHANK AT THE S1 LOCATION ON THE PATIENT'S LEFT SIDE. DESPITE SEVERAL ATTEMPTS, THE TIP OF THE DRIVER COULD NOT BE RETRIEVED. THE PRODUCT WAS EXPLANTED AND NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ALLEGATION AGAINST SCREW. THERE IS NO REVISION SURGERY SCHEDULED OR PLANNED FOR REMOVAL OF BROKEN FRAGMENT. PROCEDURE INVOLVED IN THE EVENT WAS L3-5 LATERAL FUSION, L5-S1 TLIF, L3-S1 FIXATION WITH PERC SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21444153 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT BROKE AT THE TIP. 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 21442399 ↗
• MalfunctionFeb 21, 2025Break; Break

  THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS PERCUTANEOUS FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21430291 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE DRIVER BROKEN WHEN ATTEMPTING TO REMOVE HARDWARE FROM A PATIENT USING MINIMALLY IN VASIVE TECHNIQUE. PIECES OF THE BROKEN DRIVER WERE REMOVED FROM THE PATIENT. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS A REVISION TLIF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362397 ↗