CD HORIZON® Spinal System 25100401Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169623996), received between Mar 20, 2017 and Mar 24, 2026 — classified as 4 injuries, 35 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND THE ENAMEL WITHIN THE TRAY WAS FLAKING AND CAUSING CONTAMINATION CONCERNS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. EVENTS OCCURRED ON THE BACK TABLE. INSERTER WOULD NO LONGER CLAMP DOWN ON A ROD TO SECURE THE ROD FOR INSERTION AND THE PROBE'S TIP WAS DAMAGED / CHIPPED. NOTHING PHYSICALLY BROKE OFF. THREADS WERE DAMAGE AND WOULDN'T ATTACH TO A TRIAL AND TIP OF THE DRIVER SNAPPED OFF WHILE ATTEMPTING TO ATTACH A SCREW TO THE DRIVER AND ALL INSTRUMENTS WERE PREVIOUSLY USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673274 ↗
• MalfunctionMar 24, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND THE ENAMEL WITHIN THE TRAY WAS FLAKING AND CAUSING CONTAMINATION CONCERNS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. EVENTS OCCURRED ON THE BACK TABLE. INSERTER WOULD NO LONGER CLAMP DOWN ON A ROD TO SECURE THE ROD FOR INSERTION AND THE PROBE'S TIP WAS DAMAGED / CHIPPED. NOTHING PHYSICALLY BROKE OFF. THREADS WERE DAMAGE AND WOULDN'T ATTACH TO A TRIAL AND TIP OF THE DRIVER SNAPPED OFF WHILE ATTEMPTING TO ATTACH A SCREW TO THE DRIVER AND ALL INSTRUMENTS WERE PREVIOUSLY USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673273 ↗
• MalfunctionDec 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY FOR LOWER BACK, SKIN PAIN. IT WAS REPORTED THAT THIS EVENT WAS A REPEAT SURGERY BECAUSE THE PAIN WAS CAUSED BY THE IMPLANT AND THE SET SCREW DISLODGEMENT WAS OBSERVED. LEVELS IMPLANTED FOR INITIAL SURGERY WERE L1/ILIAC. DURING IMPLANT INSERTION, THE DRIVER WAS BROKEN, SO IT COULD NOT BE INSERTED OR REMOVED ANYMORE; THE WOUND WAS CLOSED. OF THE INITIAL IMPLANTS, 1 SET SCREW PLACED IN THE ILIAC REGION WAS DETACHED, SO THIS SURGERY WAS PERFORMED AND SET SCREW WAS DISPOSED. THE IMPLANT COULD NOT BE FULLY EMBEDDED, AND THE PROCEDURE WAS CONCLUDED WITH THE IMPLANT LEFT IN PLACE. THERE WAS NO MALFUNCTION REPORTED WITH SCREW AND THERE WAS A DELAY OF MORE THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690654 ↗
• MalfunctionOct 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, STERILE PROCESSING STATED THAT THE THREADS ON THE INSTRUMENT LOOKED DAMAGED. UPON VISUAL INSPECTION THE THREADS LOOK BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308085 ↗
• MalfunctionOct 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT P LASTIC CAP BROKE OFF THE DRIVER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288138 ↗
• MalfunctionSep 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY FOR OSTEOPENIA. IT WAS REPORTED THAT DURING THE PLACEMENT OF BALLAST SCREWS USING THE POWEREASE DRIVER IN AN S2AI TRAJECTORY, A PATIENT UNDERWENT A PROCEDURE IN WHICH THE SURGEON WAS UNABLE TO FULLY DRIVE THE SCREW DUE TO THE INSERTIONAL TORQUE REQUIRED. THE USE OF A TORQUE MULTIPLIER RESULTED IN THE TIP OF THE DRIVER BREAKING OFF AND BECOMING LODGED IN THE BALLAST SCREW HEAD. THE BROKEN OFF TIP WAS REMOVED BY SURGEON DURING THE SURGERY. THE SCREW PLACEMENT WAS RIGHT ABOVE THE SCIATIC NOTCH AND DOWN THE MIDDLE OF THE "TEAR DROP" VIEW. AFTER THE FIRST DRIVER BROKE, A SECOND DRIVER WAS USED IN AN ATTEMPT TO BACK THE SCREW OUT, BUT THIS DRIVER BECAME STRIPPED. THESE DRIVERS WERE NEW DRIVERS. 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 23004741 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR POSTEROLATERAL FUSION (PLF). IT WAS REPORTED THAT THE DISTRACTOR EXPERIENCED INSTRUMENT BREAKAGE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DEVICES WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673391 ↗
• MalfunctionJul 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L2-ILLIUM POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT THE INSTRUMENT TIPS 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 22505306 ↗
• MalfunctionJul 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING LUMBAR DEGENERATIVE REVISION PROCEDURE. IT WAS REPORTED THAT THE POWEREASE BALLAST DRIVER TIP SNAPPED OFF WHILE SURGEON WAS INSERTING AN S2AI SCREW. THE TIP OF THE DRIVER WAS STUCK IN THE SCREW SHANK AND HAD TO BE PULLED OUT WITH FORCEPS WHICH TOOK ABOUT 20 MINUTES. 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 22394880 ↗
• MalfunctionMay 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR ROD FRACTURE. IT WAS REPORTED THAT THE DEVICE TIP WAS DAMAGED. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT DRIVER TIP WAS FRACTURED. THE FRACTURED ROD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976612 ↗
• MalfunctionFeb 24, 2025Break; Material Deformation; Break; Material Deformation

  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 SCREWS WERE COLD WELDED/STRIPPED DUE TO DRIVER MALFUNCTION INTRAOPERATIVELY. HAD TO HELICOPTER OUT AFTER NUMEROUS ATTEMPTS TO REMOVE USING A MULTITUDE OF DRIVERS. ONE OF THE DRIVER WAS SEVERELY WARPED AFTER ATTEMPTING TO PLACE 10.5 SCREW. WHEN ATTEMPTING TO PLACE SECOND SCREW (10.5X80) THE TORX TIP OF THE DRIVER SNAPPED OFF AND LODGED INSIDE THE TULIP/TORX INTERFACE OF THE SCREW. FRAGMENTS COULD NOT BE REMOVED AND IT WAS LEFT IN THE PT. THE OTHER DRIVER WAS SEVERELY WARPED AFTER ATTEMPTING TO PLACE 9.5 SCREW. SURGEON WAS FEARFUL OF SNAPPING OFF TIP OF THE DRIVER AGAIN SO THE DECISION WAS MADE TO HELICOPTER THE SCREW OUT AND LEAVE UNILATERAL PELVIC FIXATION. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS PSF L2-PELVIS WITH TLIF L3-5. PRE-OP DIAGNOSIS M43.16/M54.16/M40.30/M47.26. BOTH BALLAST DRIVERS WERE SEVERELY WARPED AND STRIPPED. THE PRODUCT WAS USED IN SURGERY ON THE PATIENT. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS R

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21444744 ↗
• MalfunctionFeb 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE TIGHTENING CLOSED HEADED BALLAST SCREW INTO PATIENT¿S RIGHT PELVIS. SURGEON NOT WORRIED ABOUT BROKEN DRIVER OR THE SMALL PIECE THAT BROKE OFF INSIDE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN/SCHEDULE TO REMOVE THE FRAGMENTS FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21330477 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, DRIVER SHEARED IN THE SCREW. THE DRIVER BROKE WHEN USED TO TIGHTEN A BALLAST SCREW. THERE WERE NO FRAGMENTS OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187896 ↗
• MalfunctionJan 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L2-ILLIUM SPINAL FUSION PROCEDURE DUE TO SPINAL CORD STENOSIS. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO USE THE BALLAST DRIVER TO DRIVE A BALLAST SCREW FURTHER DOWN INTO THE BONE. WHILE ATTEMPTING, THE TIP OF THE BALLAST SCREW DRIVER SNAPPED OFF. ALL BROKEN FRAGMENTS WERE RETRIEVED BUT THE SCREWDRIVER TIPS WERE DISCARDED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132967 ↗
• 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 19674172 ↗
• MalfunctionJul 3, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 PSEUDO REPAIR THERAPY. IT WAS REPORTED THAT THE BALLAST DRIVER WAS LOADED ONTO THE POWER EASE DRIVER WITH ADAPTER. SURGEON LOADED THE BALLAST CLOSED SCREW AND INSERTED THE SCREW INTO THE ILIUM. THE LAST FEW TURNS OF THE SCREW IT BECAME SUPER TIGHT AND THE DRIVER AT THE END SNAPPED OFF. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19663514 ↗
• MalfunctionFeb 10, 2023Break; Break

  THE PRE-OP DIAGNOSIS FOR THE PATIENT WAS SPINAL STENOSIS DUE TO MULTI LEVEL DISC HERNIATION. THE PROCEDURE BEING PERFORMED WAS AN L2-PELVIS SPINAL FUSION AND THE BALLAST DRIVER WAS BEING USED TO PLACE S2AI BALLAST SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16345742 ↗
• MalfunctionNov 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR AN INDICATION OF SCOLIOSIS. IT WAS REPORTED THAT THE BALLAST DRIVER TIP BROKE DURING PELVIC SCREW PLACEMENT AND THE T27 RMAS DRIVER TIP BROKE DURING REMOVAL OF SET SCREWS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERENO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833206 ↗
• MalfunctionJun 1, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT UNKNOWN SPINAL THERAPY FOR PSEUDO REPAIR L5-S1. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DRIVER WAS LOADED ONTO THE POWER EASE DRIVER AND A CLOSED 10.5X90 BALLAST SCREW WAS ATTACHED. AS THE SURGEON PLACED THE SCREW TOWARDS THE VERY LAST THREADS INTO THE ILIUM THE DRIVER BROKE AS THE BONE QUALITY WAS SUPER HARD AND HENCE DRIVER CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14561388 ↗
• MalfunctionFeb 11, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER IN A LUMBAR FUSION AT T11-PELVIS FOR A DEGENERATIVE DISC/ADULT SCOLIOSIS. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE WHILE PLACING THE SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT/ REVISION SURGERY/ DELAY IN OVERALL PROCEDURE TIME/ HOSPITALIZATION NECESSARY AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13511920 ↗
• MalfunctionOct 4, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR T2-PE LVIS REVISION. IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL INSTRUMENTS THAT WAS REPORTED ARE BROKEN. ALL THE INSTRUMENTS WERE USED AND BROKE DURING THE SAME PROCEDURE. THE LOT NUMBER OF BALLAST SCREWDRIVER IS CT15L086 (B)(4), BALLAST SCREWDRIVER LOT NUMBERS: CT21A021 (B)(4), MAS SCREW DRIVER LOT NUMBER: RS12F018 (09122013-021), RATCHETING HANDLE LOT NUMBER: 37348. THE PROCEDURE INVOLVED IN THE EVENT WAS UPSIZING SCREWS THAT WERE LOOSE AND REPLACING BROKEN RODS AND LEVELS IMPLANTED WAS T2-ILLIAC BUT ALL THE INSTRUMENTS WERE BROKEN AT THE ILIAC SCREW. THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567630 ↗
• MalfunctionSep 30, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR T2-PE LVIS REVISION. IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL INSTRUMENTS THAT WAS REPORTED ARE BROKEN. ALL THE INSTRUMENTS WERE USED AND BROKE DURING THE SAME PROCEDURE. THE LOT NUMBER OF BALLAST SCREWDRIVER IS CT15L086 (B)(4) BALLAST SCREWDRIVER LOT NUMBERS: CT21A021 (B)(4), MAS SCREW DRIVER LOT NUMBER: RS12F018 (09122013-021), RATCHETING HANDLE LOT NUMBER: 37348. THE PROCEDURE INVOLVED IN THE EVENT WAS UPSIZING SCREWS THAT WERE LOOSE AND REPLACING BROKEN RODS AND LEVELS IMPLANTED WAS T2-ILLIAC BUT ALL THE INSTRUMENTS WERE BROKEN AT THE ILIAC SCREW. THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553713 ↗
• MalfunctionAug 10, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING DRIVER AND PROBE FOR AN OPEN TLIF. IT WAS REPORTED THAT THE DRIVER AND PROBE WERE BROKEN. THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS SPINAL REVISION AND LEVELS IMPLANTED WERE T10-ILLIAC. THE PRODUCTS WERE USED IN OPERATION FIELD AND CAME IN CONTACT WITH THE PATIENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PRODUCTS WILL BE REPLACED BY MEDTRONIC PRODUCTS IN THE FUTURE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299277 ↗
• MalfunctionAug 20, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH ADJACENT SEGMENT DISEASE FOR SPINAL FUSION SURGERY. IT WAS REPORTED THAT DURING PROCEDURE THE HIGH INSERTION TORQUE OF A 9.5X90 BALLAST SCREW BROKE THE TIP OF THE DRIVER DURING ADVANCEMENT. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

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

  MAUDE report 10429922 ↗
• MalfunctionJun 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AT S2 ALAR DUE TO UNSPECIFIED REASONS. INTRA-OP, THE TIP OF THE DRIVER BROKE OFF. ALL FRAGMENTS WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10146918 ↗