CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016545Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169768277), received between Jan 4, 2022 and Feb 18, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRAN SFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF, L5¿S1) DUE TO SPINAL DEGENERATION. IT WAS REPORTED THAT AFTER SELECTING THE APPROPRIATE SCREW SIZE FOR IMPLANTATION, THE SCREW WAS IMPLANTED AND THE ROD WAS PLACED. HOWEVER, WHEN ATTEMPTING TO SECURE THE ROD, THE NUT C OULD NOT BE PROPERLY LOCKED DESPITE MULTIPLE ATTEMPTS. THE SURGEON THEN REPLACED THE SCREW WITH ANOTHER SCREW OF THE SAME SIZE, AFTER WHICH THE NUT WAS SUCCESSFULLY LOCKED AND THE SURGERY WAS COMPLETED SMOOTHLY. 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 24375423 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN FUSION THERAPY. IT WAS REPORTED THAT SCREW SHANK COMPLETELY SHEARED, TULIP AND UPPER PORTION OF SHANK DETACHED. IMPLANTS WERE PART OF AN EXISTING CONSTRUCT FROM A PREVIOUS PROCEDURE, THIS DID NOT OCCUR DURING THE COURSE OF THE OPERATION, THEY WERE DISCOVERED IN THE DESCRIBED CONDITION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT PREVIOUS PROCEDURE WAS A L5/S1 POSTERIOR FIXATION. ONGOING PROCEDURE WAS SCHEDULED TO BE A DECOMPRESSION AND REVISION +/- EXTENSION OF EXISTING CONSTRUCT. THIS WAS NOT DUE TO MALFUNCTION OF THE PRODUCT, THIS WAS DISCOVERED INTRA-OP. PATIENT WAS EXPERIENCING PAIN AND REQUIRED DECOMPRESSION AND REVISION +/- EXTENSION OF EXISTING CONSTRUCT.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 21304296 ↗
• MalfunctionApr 26, 2024Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE VOYAGER SCREWS THAT CAME IN FOR RESTOCK WERE BENT. THEY WERE NOT PUT IN THE SET AS THEY ARE NOT USABLE. 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 19189016 ↗
• InjuryJun 22, 2023Unintended Movement; Unintended Movement

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED SCREWS. IT WAS REPORTED THAT, PATIENT HAD L5/S1 POSTERIOR LUMBAR FIXATION IN (B)(6) 2021. PATIENT COMPLAINED OF PAIN IN (B)(6) 2022, AND RADIOLOGICAL REPORTS HIGHLIGHTED A PEDICLE BREACH AT L5 WITH NO APPARENT IMPLANT FAILINGS. REVISION WAS PERFORMED ON (B)(6) 2023 AND DURING THE PROCEDURE IT WAS FOUND THAT THE S1 SCREW HAD BROKEN AND PARTIALLY EXPLANTED AND L5 SCREW WAS REPLACED. THE BROKEN FRAGMENT WAS LEFT INSIDE THE BONE AND SURGERY WAS ABANDONED FOR A REVISION AT A LATER DATE. THERE WAS NO PATIENT SYMPTOM REPORTED AS A RESULT OF BROKEN SCREW. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED. THE L5 SCREW HAD BREACHED THE PEDICLE. DURING THE PROCEDURE TO REPLACE THE L5 SCREW, IT BECAME APPARENT THAT THE S1 SCREW HAD BROKEN. IT IS UNCLEAR WHEN THIS SCREW FRACTURED. THE MRI SCAN IDENTIFIED THE BREACH IN (B)(6) 2022 SHOWED THAT THE L5 SCREW HAD BREACHED THE PEDICLE BY BEING INFERIOR AND MEDIAL IN THE PEDICLE.

  Patient problems: Pain

  MAUDE report 17180592 ↗
• InjuryJun 5, 2023Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17057711 ↗
• InjuryJun 5, 2023Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17057581 ↗
• InjuryApr 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD SCREW EXPLANT (MIS L5-S1 TLIF). PRE OP DIAGNOSIS WAS SPONDYLOLISTHESIS. IT WAS REPORTED THAT BOTH L5 SCREWS BROKE UNDERNEATH THE TULIP POST SURGE RY. REVISION SURGERY WAS PERFORMED WITH REPLACEMENT OF SCREWS AND EXTENSION TO PELVIS. 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 16760593 ↗
• MalfunctionDec 1, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVAS IVE POSTERIOR LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT, THE SET SCREW WAS TIGHTENED DOWN TO THE ROD. WHEN THE SURGEON WENT TO TORQUE OFF THE SET SCREW, THE SET SCREW KEPT SPINNING AND WAS NOT BREAKING OFF. DIFFERENT ADDITIONAL SET SCREWS WERE TRIED BUT THOSE WERE NOT TORQUED OFF EITHER. EVENTUALLY, THE SCREW HAD TO BE REPLACED AND THEN THE SET SCREW TORQUED OFF. IT WAS BELIEVED TO BE THE EXTENDER TABS WERE SLIGHTLY BENT CAUSING THE SET SCREW TO CROSS THREAD AND CAUSING IT TO SPIN INSTEAD OF TORQUEING OFF. IT IS NOT ABLE TO BE CONFIRMED DEFINITIVELY THAT THE SCREW WAS THE CAUSE OF THE ISSUE BUT AFTER FURTHER INVESTIGATION, THE BENT TABS SEEM TO HAVE BEEN THE ISSUE AND NOT THE SET SCREW. THE SURGEON STATED HE MEDIALIZED BOTH SCREWS WHICH COULD HAVE CAUSED THE TABS TO BEND. THE PEDICLE SCREW CAME INTO CONTACT WITH THE PATIENT BECAUSE IT WAS INSERTED INTO THE PEDICLE. THE SCREW WAS LATER REMOVED AND REPLACED. THE ALLEGED SCREW WAS NOT FOUND, MOST LIKELY IT WAS THROWN AWAY OR LOST. THE SURGEON FOLLOWED IFU/LABELLING THROUGH OUT THE PROCEDURE. THERE WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892513 ↗
• InjuryJul 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A PERCUTANEOUS PSF AT T10-L2. IT WAS REPORTED THAT THE SCREWS MALFUNCTIONED SOMETIME BETWEEN IMPLANT AND REMOVAL, LIKELY DURING ONE OF THE PATIENT'S FALLS. UPON EXPLANTATION, THE HCP NOTICED THAT THE SCREWS TULIPS WERE WELDED TO THE SHANK IN A WAY THAT THE POLY AXIAL RANGE OF MOTION WAS LOST AND THE TULIP WAS ¿FIXATED¿ AT A DIFFERENT DEGREE FOR EACH OF THE RESPECTIVE SCREWS. THE SURGEON WAS UNABLE TO PUT THE SHANK OF THE DRIVER THROUGH THE TULIP TO SEAT IT INSIDE OF THE SCREW SHANK BECAUSE THE FIXATED TULIP WAS BLOCKING A STRAIGHT PATH WAY FOR THE DRIVER TO SEAT. THE MALFUNCTIONING OF THE SCREWS WAS LIKELY DUE TO A FALL. THE PATIENT IS OSTEOPOROTIC AND THE SCREWS WERE HALOING SEVERELY AND LOOSE. THE PATIENT HAS HAD MULTIPLE FALLS. THE HCP DETERMINED THAT THE SCREWS DID NOT STABILIZE THE PATIENT AS HE HAD HOPED. THE SURGEON DECIDED TO REMOVE HARDWARE AS PART OF HER PREVENTATIVE TREATMENT PLAN AND AT THE TIME OF THE HARDWARE REMOVAL, HE NOTICED THE SCREW MALFUNCTION. THERE IS NO INJURY TO THE PATIENT DUE TO THE SCREW MALFUNCTION. THE DATE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913678 ↗
• MalfunctionJan 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICA TION FOR SPINAL THERAPY. IT WAS REPORTED THAT AFTER A LUMBAR RESTORATION, THE SCREW BROKE. PRODUCT WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT PROCEDURE INVOLVED WAS SPONDYLODESE L5-S1. THERE WERE TWO BROKEN SCREWS..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155258 ↗
• MalfunctionJan 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICA TION FOR SPINAL THERAPY. IT WAS REPORTED THAT AFTER A LUMBAR RESTORATION, THE SCREW BROKE. PRODUCT WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT PROCEDURE INVOLVED WAS SPONDYLODESE L5-S1. THERE WERE TWO BROKEN SCREWS..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155185 ↗