CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017545Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169501126), received between Oct 25, 2017 and Mar 28, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. LEVELS IMPLANTED WERE L4/5. IT WAS REPORTED THAT THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2024. DURING THIS PROCEDURE, A CAGE WAS INSERTED, AND MUSCLE SUTURING WAS PERFORMED. SUBSEQUENTLY, SCREWS WERE INSERTED TRANSFASCIALLY FROM THE CAGE INSERTION SIDE, COMPRESSION WAS APPLIED, AND THE CONTRALATERAL SCREW WAS INSERTED. THE REASON FOR THE REPEAT SURGERY WAS DUE TO THE AA BACKING OUT AND PROTRUDING INTO THE SPINAL CANAL. THE AA WAS REMOVED AND REPLACED WITH PT AND THE LOOSENED SCREW WAS REPLACED. DELAY IN THE OVERALL PROCEDURE WAS GREATER THAN 60 MINUTES. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION AA IS ADAPTIX (REPORTED DEVICE) PT IS CAPSTONE PTC AND HA IS HA STICK. PATIENT EXPERIENCED BONE NONUNION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21718088 ↗
• MalfunctionJan 6, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS IN A LUMBAR POSTERIOR FUSION FOR A LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE EXTENDER TAB WAS ATTACHED TO THE SCREW, BUT THE SITUATION WAS THAT THE ATTACHMENT WAS LOOSE AND CAME OFF EASILY (FOR BOTH SCREWS). THE OPERATION WAS SUCCESSFULLY COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THE SCREWS WERE NEVER IMPLANTED. THE PRODUCTS HAD NO CONTACT WITH THE PATIENT. 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 21078314 ↗
• MalfunctionJun 21, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION FOR L3/4 LCS. IT WAS REPORTED THAT AFTER INSERTING THE SCREW, IT WAS REMOVED ONCE IN ORDER TO CHANGE THE SCREW ORIENTATION. AFTER THAT, WHEN THE SCREW WAS TRIED TO BE INSTALLED ON THE SCREWDRIVER AGAIN, IT COULD NOT BE INSTALLED ON THE SCREWDRIVER. BECAUSE OF THAT, A NEW SCREW WAS OPENED AND USED. THE DRIVER COULD BE INSTALLED AND USED WITHOUT ANY PROBLEM EXCEPT WITH THIS SCREW. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINUTES. 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 19580681 ↗
• MalfunctionMay 27, 2022Mechanics Altered; Mechanics Altered

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521069 ↗
• MalfunctionJun 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-S1 RE-DECOMPRESSION AND FIXATION; AND L4-S1 POSTERIOR LUMBAR INTERBODY FUSION. INTRA-OP, WHILE PERFORMING FINAL TIGHTENING OF THE LEFT SIDE L4 SET SCREW WITH THE DRIVER, THE SET SCREW DID NOT GET CAUGHT BY THE DRIVER. WHEN THE IMAGES WERE CHECKED, SET SCREW WAS FOUND TO BE DEVIATED TOWARDS THE CAUDAL SIDE. THE REPORTED SET SCREW WAS REPLACED WITH A NEW ONE; BUT WHILE INSERTING A NEW SET SCREW, THE TAB OF THE SCREW BROKE. SO, FINAL TIGHTENING COULD NOT BE PERFORMED AT THIS SITE; BUT ALL OF THE LEFT SITES WERE TIGHTENED AND THE OPERATION WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745165 ↗
• InjuryFeb 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PROCEDURE: MINIMALLY INVASIVE SPINAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PRE-OPERATIVE DIAGNOSIS: NEUROLOGICAL SYMPTOM IT WAS REPORTED THAT POST-OP, SCREW WAS LOOSE. REVISION SURGERY WAS PERFORMED DUE TO SCREW LOOSING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8347499 ↗
• InjuryFeb 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PROCEDURE: MINIMALLY INVASIVE SPINAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PRE-OPERATIVE DIAGNOSIS: NEUROLOGICAL SYMPTOM IT WAS REPORTED THAT POST-OP, SCREW WAS LOOSE. REVISION SURGERY WAS PERFORMED DUE TO SCREW LOOSING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8347498 ↗
• InjuryDec 5, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH L4 BURST FRACTURE AND UNDERWENT SPINAL FUSION PROCEDURE. POST-OP, THE SCREW AT THE RIGHT SIDE OF L5 WAS BROKEN. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081858 ↗
• InjuryOct 25, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION ON L5/S (TLIF) DUE TO SPINAL CANAL STENOSIS. POST-OP, THE SCREW ON THE RIGHT SIDE OF SACRUM S1 BROKE FROM THE BASE. CAUDA EQUINA SYMPTOM AND LOWER LIMB PAIN WERE DEVELOPED TO THE PATIENT AS A RESULT OF THIS EVENT. IT IS CONSIDERED THAT BONE UNION HAS NOT BEEN ACHIEVED AT L5/S. THE PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF BROKEN SCREW.

  Patient problems: Pain; Spinal Cord Injury

  MAUDE report 6975541 ↗