N/A 815-517Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00673978045085), received between Nov 26, 2018 and Jul 30, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50078736 ↗
• MalfunctionFeb 13, 2026Break; Material Deformation

  INFORMATION WAS RECEIVED FROM USE FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS R EPORTED THAT DRIVERS WERE STRIPPED AND BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339801 ↗
• MalfunctionFeb 13, 2026Break; Material Deformation

  INFORMATION WAS RECEIVED FROM USE FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS R EPORTED THAT DRIVERS WERE STRIPPED AND BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339780 ↗
• MalfunctionAug 8, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING HARDWARE REMOVAL/REINSTRUMENTATION FOR NON UNION. IT WAS REPORTED THAT THE TIP OF DRIVER SNAPPED OFF. THE PIECE THAT BROKE OFF WAS RETRIEVED. 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 17485221 ↗
• MalfunctionJun 6, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR SPINAL FUSION FOR SPINAL STENOSIS AND SPONDOLOLYSTHESES. LEVELS IMPLANTED WERE LUMBAR 3 <(>&<)> SACRAL 2. IT WAS REPORTED THAT INSTRUMENT TIP WAS BROKEN WHILE ATTEMPTING TO REMOVE A SET CAP, THE TIP WAS FOUND AND DISCARDED. NO PATIENT SYMPTOMPS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073145 ↗
• MalfunctionMay 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT IS USED IN SPINAL THERAPY FOR HARDWARE REMOVAL. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SY MPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937491 ↗
• MalfunctionMay 1, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SET SCREWS USING A DRIVER IN A SPINAL FUSION FOR SPINAL DEGENERATION. IT WAS REPORTED THAT THAT DURING THE TIGHTENING OF SET SCREWS, THE TIP OF THE T-20 DRIVER BROKE OFF. THE BROKEN PIECE WAS RECOVERED WITH NO INJURY TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842711 ↗
• MalfunctionApr 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PROXIMAL BREAK DOWN AND STENOSIS. IT WAS REPORTED THAT SURGEON OVER TIGHTENED AND BROKE THE TIP OFF OF THE DRIVER SHAFT IN THE SCREW. THE BROKEN TIP THAT REMAINED INSIDE OF SCREW HEAD WAS DISCARDED. HENCE, NO FRAGMENTS LEFT INSIDE THE PATIENT BODY. 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 16760100 ↗
• MalfunctionMar 29, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL INSTRUMENTATION REVISION. IT WAS REPORTED THAT WHILE REVISING SPINAL HARDWARE, DEVICES WERE BROKEN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRODUCTS CAME IN CONTACT WITH PATIENT. THERE ARE NO BROKEN FRAGMENTS LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16634566 ↗
• MalfunctionDec 13, 2022Break; 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 15967981 ↗
• MalfunctionNov 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED IN POSTERIOR SPINAL FUSION AND REVISION OF EXISTING HARDWARE AND EXTENSION OF EXISTING FUSION BETWEEN T11 AND L3. PRE-OPERATIVE DIAGNOSIS: PJK, LEVELS IMPLANTED: EXISTING CONSTRUCT AT T7-T11, EXISTING CONSTRUCT L4-S1, INSTRUMENTATION PLACED IN BETWEEN T12-L3 IT WAS REPORTED THAT WHILE TIGHTENING A SET SCREW ON A DOMINO CONNECTING THE NEW AND EXISTING ROD, THE TIP OF THE DRIVER BROKE OFF. IT WAS LODGED INTO THE SET SCREW OF THE DOMINO AND LEFT AT THE TIME. IT WAS NOT BELIEVED TO BE REMOVED THROUGHOUT THE REST OF THE PROCEDURE. TO DATE THERE HAVE BEEN NO REPORTED ISSUES WITH THE PATIENT. THERE WAS NO EVIDENCE THAT IT HAD BECOME DISLODGED INTRAOPERATIVELY AND WAS FLOATING LOOSE IN THE WOUND UPON EXAMS WITH X-RAY. AT THIS TIME IT IS BELIEVED TO BE LODGED INSIDE THE SET SCREW OF THE DOMINO. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT MEDICAL HISTORY: PATIENT UNDERWENT A REVISION SURGERY FOR PJK. THERE WAS EXISTING INSTRUMENTATION IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15877094 ↗
• MalfunctionSep 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR DDD. PROCEDURE OR THERAPY PERFORMED WAS T10 TO PELVIS REVISION AND POSTERIOR FUSION. LEVELS IMPLANTED T10-S2. PATIENT HAD A MEDICAL HISTORY OF DEGENERATIVE DISC DISEASE AND HISTORY OF SMOKING BUT NOT WITHIN LAST 6 MONTH. IT WAS REPORTED THAT THE SURGEON IMPLANTED CAGE, EXPANDED CAGE THEN COLLAPSED CAGE TO MODIFY PLACEMENT. SURGEON THEN ALLEGED THE INSERTER DIDN¿T FEEL TIGHT ON THE IMPLANT. HE TRIED TO TIGHTEN INNER COLLAR AS SNUG AS POSSIBLE TO SECURE IMPLANT BUT IT SEEMED LOOSE. HE ATTEMPTED TO EXPAND THE CAGE AND THE EXPANSION DRIVER WOULDN¿T GO DOWN ALL THE WAY AND CAGE WOULDN¿T EXPAND. HE THEN EXPLANTED THE IMPLANT TO INSPECT IT. CAGE WAS REMOVED FROM INSERTER AND REATTACHED. PRIOR TO IMPLANTING HE ATTEMPTED TO EXPAND CAGE AND IT WOULD NOT EXPAND. SURGEON SWITCHED TO A DIFFERENT INNER CANNULA AND EXPERIENCED SIMILAR EXPANSION DIFFICULTY. SURGEON ENDED UP SWITCHING TO NEW CAGE AND FINISHED SURGERY. EXPLANTED IMPLANT AND RE-IMPLANT THE NEW CAGE RESULTED IN 20-30 MINUTE DELAY. AFTER SURGERY CAGE WAS INSPECTED AND CLEANED TRIED TO GET CAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444205 ↗
• MalfunctionMay 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR DDD REVISION DUE TO INFECTION. IT WAS REPORTED THAT THE END OF THE INSTRUMENTS BROKE DUE TO THE SET SCREWS BEING TOO TIGHT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14393032 ↗
• MalfunctionApr 11, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT FUSION S PINAL THERAPY FOR L3-4 STENOSIS AND L4-5 REMOVAL OF HARDWARE. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE SET SCREWS, THE DRIVERS BROKE OFF. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS WERE USED IN SAME EVENT. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072504 ↗
• MalfunctionApr 11, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT FUSION S PINAL THERAPY FOR L3-4 STENOSIS AND L4-5 REMOVAL OF HARDWARE. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE SET SCREWS, THE DRIVERS BROKE OFF. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS WERE USED IN SAME EVENT. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072343 ↗
• MalfunctionFeb 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CONNECTOR USING A TORX SHAFT IN A PSF FOR A BURST FRACTURE AT T6-T10. IT WAS REPORTED THAT DURING FINAL TIGHTENING OF THE CONNECTOR, THE SHAFT TIP SHEARED OFF. THE TIP FRAGMENT WAS REMOVED FROM THE PATIENT AND NEW DRIVER WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13520633 ↗
• MalfunctionJan 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- SPINAL STENOSIS INVOLVED IN THE REPORTED EVENT. IT WAS REPORTED THAT DURING PROCEDURE, WHEN FINAL TIGHTENING ONE OF THE AXIAL CONNECTORS SET SCREWS THE TIP OF THE DRIVER SHEARED OFF. SURGEON WAS ABLE TO REMOVE THE BROKEN FRAGMENT AND USED AN ALTERNATE DRIVER TO FINISH SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON 2022-JAN-12, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERAPY INVOLVED IN THE REPORTED EVENT WAS POSTERIOR CERVICAL AND THORACIC SPINAL FUSION PROCEDURE. LEVELS IMPLANTED/TREATED IN THE REPORTED EVENT: C7-T12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13383483 ↗
• MalfunctionJan 3, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH A MEDICAL HISTORY OF DEGENERATIVE DISC DISEASE <(>&<)> PRE-OPERATIVE DIAGNOSIS FOR LUMBAR STENOSIS. PROCEDURE OR TECHNIQUE USED WAS HARDWARE REMOVAL. IT WAS REPORTED THAT DURING HARDWARE REMOVAL TIP OF THE DRIVER BROKE IN THE CONNECTOR SET SCREW WHERE IT REMAINED WITH NO INJURY TO THE PATIENT. SURGEON WAS ABLE TO REMOVE HARDWARE WITH NO FURTHER ISSUES. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE TIP OF THE BROKEN INSTRUMENT WAS STUCK IN ONE OF THE SET SCREWS THAT WAS REMOVED FROM THE PATIENT DURING THE HARDWARE REMOVAL. NO FURTHER SURGERY WILL BE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13147958 ↗
• MalfunctionDec 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN AXIAL CONNECTOR USING DRIVERS IN A HARDWARE REVISION AT L4-PELVIS. IT WAS REPORTED THAT WHILE TIGHTENING SET SCREWS ON AXIAL CONNECTOR, THE DRIVERS BROKE. THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES PSEUDO ARTHROSIS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023789 ↗
• MalfunctionDec 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN AXIAL CONNECTOR USING DRIVERS IN A HARDWARE REVISION AT L4-PELVIS. IT WAS REPORTED THAT WHILE TIGHTENING SET SCREWS ON AXIAL CONNECTOR, THE DRIVERS BROKE. THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES PSEUDO ARTHROSIS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023788 ↗
• MalfunctionDec 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SET SCREWS AND POLYAXIAL SCREWS USING DRIVERS IN A REVISION POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT DURING THE EXPLANTATION OF A PREVIOUSLY IMPLANTED NON-MDT CONSTRUCT, MULTIPLE DRIVERS TIPS WERE BROKEN AT DIFFERENT TIMES WHILE ATTEMPTING TO REMOVE THE SET SCREWS AND POLY AXIAL SCREWS. THE BROKEN TIPS WERE ALL IDENTIFIED AND DISCARDED. POST-OPERATIVE IMAGING CONFIRMED THAT THERE WERE NO METAL FRAGMENTS REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF PROBABLY 10 MINUTES IN OVERALL PROCEDURE TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914735 ↗
• MalfunctionJul 30, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DRIVER FOR REMOVING A SET SCREW. IT WAS REPORTED THAT THE TIP OF DRIVER BROKE DURING ATTEMPTED SET SCREW REMOVAL. THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRODUCT WAS USED IN THE OPERATING FIELD, AND IT WAS USED ON THE PATIENT IN ORDER TO REMOVE THE IMPLANTS. THE PRE-OP DIAGNOSIS WAS SCREWS LOOSENED FROM PREVIOUS CONSTRUCT. THE SCREWS EXPLANTED WERE MDT PRODUCTS. THERE WERE NO LEVELS IMPLANTED, AS THIS WAS A REVISION SURGERY, AND IMPLANTS WERE BEING REMOVED. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251214 ↗
• MalfunctionJul 14, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH DEGENERATIVE DISK DISEASE FOR SINGLE POSITION OLIF SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEERED OFF IN THE SCREW. THE SHAFT HAS STRIPPED OVER TIME. PART CAME IN CONTACT WITH PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164818 ↗
• MalfunctionJun 29, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF STENOSIS AND RADIC ULOPATHY INVOLVED IN REVISION OF PAST IMPLANTS. IT WAS REPORTED THAT DURING PROCEDURE, BOTH TRIAL HANDLE AND THE TRIAL WERE STRIPPED, THEY WOULD NOT SEPARATE. PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT IN THE REPORTED EVENT T10 TO PELVIS REVISION WAS PERFORMED. DRIVERS STRIPPED DURING REMOVALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085910 ↗
• MalfunctionJun 24, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION DUE TO L2-S1 REVISION. IT WAS REPORTED THAT SCREWDRIVER IS STRIPPED. THE SCREWDRIVER CAME INTO CONTACT WITH THE IMPLANT IN THE PATIENT.  THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055935 ↗