CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550002Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169754492), received between Oct 18, 2018 and Dec 3, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Degraded; Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT MULTIPLE INSTRUMENTS AND DRIVERS WERE REPORTED AS BROKEN. SPECIFICALLY, THE TIP OF THE DRIVER WAS NOTED AS BROKEN FOR PLI 30 AND 40. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE RATCHET HANDLES REVERSE/FORWARD MECHANISM NO LONGER FUNCTIONING, ALL THE DRIVERS TIP WORN DOWN, AND FOR THE OTHER INSTRUMENTS TUBE NO LONGER FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701639 ↗
• MalfunctionAug 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER EXPERIENCED INSTRUMENT BREAKAGE AND THE ANOTHER DRIVER HAD A TIP THAT WAS BROKEN AND TWISTED. 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 22892360 ↗
• MalfunctionAug 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIPS OF THE DRIVERS WERE SHEARED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736193 ↗
• MalfunctionAug 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT; THE TIPS OF THE DRIVERS WERE SHEARED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736180 ↗
• MalfunctionJul 11, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. 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 22477498 ↗
• MalfunctionMay 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVER T25 TIP WAS BROKEN OFF WHILE SETTING UP FOR A PROCEDURE. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COM PLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966628 ↗
• MalfunctionMar 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION FOR AN INDICATION OF TRAUMA <(>&<)> LISTHÉSIS. IT WAS REPORTED THAT THE TIP OF SCREWDRIVER WAS BROKEN DURING FINAL ILIAC SCREW INSERTION AND THE BROKEN TORX TIPS OF RELATED SCREWDRIVERS REMAIN IN THE IMPLANTED SCREWS. THERE IS NO PLAN OF REVISION SURGERY FOR REMOVAL OF DEVICE FRAGMENTS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21615979 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT HAVING L3-4; L 5-S1 WITH REMOVAL OF HARDWARE L4-5 FOR STENOSIS AND DISC DISEASE. IT WAS REPORTED THAT THE TIPS BROKE. IT WAS VERY SCLEROTIC BONE ON A REVISION. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT AS WHEN INSERTING SCREWS, THE TIPS OF THE SCREW DRIVERS TWISTED. ANY FRAGMENT WAS RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443784 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING PRODUCTS USED FOR SPINAL THERA PY. IT WAS REPORTED THAT THE TIP OF THE DRIVERS WERE BROKEN AND SHEERED OFF, CAUSING IT TO NOT SEAT PROPERLY IN THE HEAD OF SCREWS. ADDITIONALLY, THE RETAINING CLIPS ON THE TIP BROKE OFF, NO LONGER RETAINING THE OBTURATOR DRIVER. FURTHERMORE, THE PROBE OF THE FEELER WAS BENT AND WOULD NOT RETURN TO NORMAL. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354046 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS BROKEN. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289867 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A REVISION SURGERY DUE TO LOWER BACK PAIN, DUE TO THE LOOSENESS OF THE L5 SCREW, THERE WAS CONCERN ABOUT INTERVERTEBRAL INSTABILITY AT L4/5 AFTER THE INITIAL L4/5 OLIF PROCEDURE. IT WAS REPORTED THAT AFTER REMOVING THE LEFT L4 SCREW, THE REPORTED PRODUCT SV56 CNMAS 7.5X50 WAS ATTACHED TO THE RETAINING SCREWDRIVER AND INSERTED. THE TORQUE WAS APPLIED DURING THE INSERTION OF THE PPS AND THE TIP PORTION OF THE RETAINING SCREWDRIVER WAS BROKEN AND REMAINS IN THE SV56 CNMAS 7.5X50. THE CUT ROD WAS FINALLY TIGHTENED AND THE SV56 CNMAS 7.5X50 WAS REMOVED. LOOSENING WAS OBSERVED IN THE TWO SCREWS ON THE LEFT AND RIGHT SIDES OF L5. RELATIONSHIP BETWEEN "LOWER BACK PAIN" AND "LOOSENING OF THE L5 SCREW" IS UNKNOWN. THE PHYSICIAN BELIEVED THAT THE L5 LOOSENING OCCURRED AND A FINE MOVEMENT MIGHT REMAIN IN BETWEEN THE VERTEBRAE ON L4/5. THE LOOSENED L5 SCREW WAS REMOVED DURING REPEAT SURGERY AND REPLACED WITH MEDTRONIC PRODUCT. FRAGMENT OF THE SCREWDRIVER TIP REMAINED IN THE CORE OF THE SCREW. IT BECAME DIFFICULT TO REMOVE. IN THE END, IT WAS REMOVED. THERE WAS NO PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280949 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING INSTRUMENTS USED IN UNKNOWN SP INAL THERAPY. IT WAS REPORTED THAT DRIVERS 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 21280855 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND THAT THE DRIVERS WERE BROKEN WHILE RESETTING THE TRAYS. 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 21237029 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DRIVERS. IT WAS REPORTED THAT DURING USE BROKEN TIPS FOR EACH DRIVER. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186550 ↗
• MalfunctionNov 11, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE THERAPY INVOLVED IS LUMBAR FUSION. THERE IS NO MALFUNCTION WITH THE PRODUCTS USED IN THE INITIAL SURGERY WHICH WAS DONE DUE TO THE SCLEROTIC BONE FORMED AFTER ORIGINAL SURGERY AND UPON REPLACING HARDWARE THE SCREW DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650189 ↗
• MalfunctionNov 11, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW DRIVER TIP BROKE DUE TO SCLEROTIC BONE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE THERAPY INVOLVED IS LUMBAR FUSION. THERE IS NO MALFUNCTION WITH THE PRODUCTS USED IN THE INITIAL SURGERY WHICH WAS DONE DUE TO THE SCLEROTIC BONE FORMED AFTER ORIGINAL SURGERY AND UPON REPLACING HARDWARE THE SCREW DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650171 ↗
• MalfunctionAug 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE TIP OF DRIVER WAS SHEARED OFF WHEN IMPLANTING A SCREW AT RIGHT L5 LEVEL. SURGEON WAS PERFORMING AN L4-S1 MINIMALLY INVASIVE SURGERY - TRANSFORAMINAL LUMBAR INTERBODY FUSION. DURING INSERTION OF THE PEDICLE SCREW INTO THE RIGHT L5 OF THE PATIENT, THE SURGEON ENCOUNTERED SCLEROTIC BONE, WHICH MADE ADVANCING THE SCREW EXTREMELY DIFFICULT. AT ONE POINT, THE SCREW WAS NOT ABLE TO BE MOVED AND SOME FORCE WAS NEEDED TO ADVANCE THE SCREW. THE SCREW DID NOT ADVANCE, BUT THE TIP OF THE SCREWDRIVER SHEARED OFF INTO THE SHANK. THE DRIVER WAS REMOVED FROM THE SCREW. AND, THE SCREW WAS ALSO REMOVED AS THE SCREW WAS NOT PLACED DEEP ENOUGH FOR ROD INSERTION. ONCE REMOVED, THE SURGEON SKIPPED THAT LEVEL, AND PROCEEDED TO THE S1 LEVEL. A ROD WAS PLACED FROM L4 TO S1. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969996 ↗
• MalfunctionJul 16, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR LCS. PROCEDURE PERFORMED WAS L2-S2AI FIXATION. IT WAS REPORTED THAT THE SCREWDRIVER FRACTURE. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME OF LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747470 ↗
• MalfunctionJul 16, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR LCS. PROCEDURE PERFORMED WAS L2-S2AI FIXATION. IT WAS REPORTED THAT THE SCREWDRIVER FRACTURE. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME OF LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747459 ↗
• MalfunctionNov 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN L 3-S PERCUTANEOUS PEDICLE SCREW (PPS) FIXATION SPINAL THERAPY FOR L3/S DEGENERATIVE SCOLIOSIS. LEVELS IMPLANTED WAS L3-S. IT WAS REPORTED THAT DURING INSERTION OF S1 SCREW, THE SCREWDRIVER BROKE JUST AS THE SCREW WAS BEING INSERTED DUE TO HARDNESS OF THE BONE. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO FRAGMENTS LEFT IN THE PATIENT BODY, SO NO PLAN FOR REVISION SURGERY. THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH THE MDT SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180374 ↗
• MalfunctionNov 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TLIF FOR ADJACENT SEGMENT DISEASE OF L3/4. IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS BROKEN. THE TIP OF THE SCREWDRIVER IS BURIED IN THE SCREW HEAD AND CANNOT BE REMOVED. DURING THIS PROCEDURE THE ROD USED IN THE PREVIOUS OPERATION ON (B)(6) 2020 WAS PLACED IN THE SCREW WITH A SET SCREW, AND EACH SCREW WAS REMOVED. THERE WAS A DELAY OF LESS THAN 60 MINUTES DUE TO THIS EVENT. EXPLANT DATE OF THE SET SCREW WAS (B)(6) 2022. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842313 ↗
• MalfunctionAug 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN TRANSFORAMINAL INTERBODY LUMBAR FUSION(TLIF). IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. THE LEVELS IMPLANTED WERE L4/5. THE PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS TRANSFORAMINAL INTERBODY LUMBAR FUSION(TLIF). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. HENCE, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SCREW DRIVER BROKE AT THE TIP AND NO ALLEGATION OF ISSUES WITH THE SCREW. THE PATIENTS BONE WAS EXCEEDINGLY HARD AND CAUSED THE DRIVER TO BREAK. THE INSERTER WAS DAMAGED AND THE NAV TRACKER NO LONGER ROTATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257206 ↗
• MalfunctionJan 3, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13140717 ↗
• MalfunctionDec 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR PYOGENIC SPONDYLITIS. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE AND WAS STUCK IN THE SCREW HEAD AND COULD NOT BE REMOVED. FRAGMENTS OF THE INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO, ANY TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PROCEDURE OR THERAPY PERFORMED WAS LUMBAR ANTEROPOSTERIOR FUSION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12958096 ↗
• MalfunctionJun 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE PREVIOUS L3-5 FUSION. IT WAS REPORTED THAT, THE DRIVER'S WERE BROKEN. BOTH DRIVERS WERE BROKEN WHEN THE SURGEON WAS TRYING TO ADVANCE AN 8.5MM VOYAGER SCREW, DUE TO EXTREMELY HARD BONE.  THE PATIENT HAD A PREVIOUS L3-5 FUSION. IT WAS MENTIONED THAT, THEY PULLED OUT ALL SCREWS, EXTENDED UP TO L2 AND DOWN TO THE PELVIS. AT L3-5, THE SCREWS WERE UPSIZED. ONE OF THE LEVELS HAD REALLY HARD, SCLEROTIC BONE REQUIRING HIGH TORQUE TO FINAL POSITION THE 8.5MM SCREW, WHICH IS WHERE BOTH DRIVERS WERE DAMAGED.  THIS PROCEDURE WAS REVISION FOR L3-5. THE REASON FOR REVISION WAS PATIENT HAD ADJACENT SEGMENT DISEASE AT LEVEL L2-L3, THAT NEEDED TO EXTEND UP AND DOWN. THERE WAS NO MALFUNCTION OF PRODUCTS USED IN INITIAL SURGERY LEAD TO THIS REVISION. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945563 ↗