CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017540Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169501133), received between May 9, 2018 and Mar 28, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 10 most recent of 10 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 21718095 ↗
• 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 TRANSFACIAL 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 21718032 ↗
• MalfunctionDec 31, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/4 TLIF AND L 3/4/5 POSTERIOR FIXATION FOR L3/4 SPONDYLOLISTHESIS, L2/3 LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT AFTER L2/3 DECOMPRESSION, PEDICLE SCREW WAS INSERTED INTO L3/4/5 USING PPS. AFTER THAT, THE ROD WAS INSERTED INTO THE RIGHT L3/4/5, AND WHEN THE SET SCREW APPROACHED L4, A CROSS-THREADING AND IDLING EVENT OCCURRED. AFTER THAT, THE SCREW WAS REPLACED, BUT STILL, A SIMILAR EVENT REMAINED. IMPROVEMENT WAS ATTEMPTED BY REPLACING THE SET SCREW ETC. SEVERAL TIMES, BUT IT DID NOT IMPROVE; IT IMPROVED WHEN THE L4 SET SCREW WAS RETIGHTENED USING THE RETAINING SCREWDRIVER FROM THE POINT OF IDLING. AFTER THAT, THE SET SCREWDRIVER WAS INSERTED AND FINAL TIGHTENING WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. 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 21046460 ↗
• MalfunctionJun 17, 2020Break; Break

  INTRA OP, DRIVER'S TIP BROKE OFF WHEN ATTEMPTING TO REMOVE THE SCREW. THE BROKEN TIP OF THE DRIVER IS REMAINING IN THE SCREW LEFT IN THE PATIENT'S BODY. TWO SCREWS REMAIN IN THE L5 VERTEBRAL BODY. THERE WAS A DELAY OF 30 MIN IN OVERALL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162122 ↗
• InjuryJun 17, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE PERFORMED: CAGE REPLACEMENT & SCREW REPLACEMENT LEVELS IMPLANTED: L5/S POST OP, THROUGH POSTOPERATIVE IMAGE DIAGNOSIS ONE MONTH AFTER DISCHARGE, IT WAS FOUND THAT THE LEFT SCREWS WERE LOOSE SO SCREWS REPLACEMENT WAS PERFORMED. THE SCREWS WERE REMOVED AND WERE REPLACED WITH UPPER SIZED SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162028 ↗
• InjuryJun 17, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE PERFORMED: CAGE REPLACEMENT SCREW REPLACEMENT LEVELS IMPLANTED: L5/S POST OP, THROUGH POSTOPERATIVE IMAGE DIAGNOSIS ONE MONTH AFTER DISCHARGE, IT WAS FOUND THAT THE LEFT SCREWS WERE LOOSE SO SCREWS REPLACEMENT WAS PERFORMED. THE SCREWS WERE REMOVED AND WERE REPLACED WITH UPPER SIZED SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162012 ↗
• 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 8347497 ↗
• InjuryNov 12, 2018Loosening 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8062093 ↗
• MalfunctionJul 17, 2018Break

  TYPE OF PROCEDURE OR TECHNIQUE USED : POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AT L5/S IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISC HERNIATION AT L5/S. INTRA-OP, WHEN SET SCREW WAS PLACED FOR PROVISIONALLY FIXING AFTER INSERTING SCREW AND PLACING ROD, THE SCREW HEAD OPENED, AND THE THREAD INSIDE THE SCREW HEAD WAS BROKEN. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 7696962 ↗
• InjuryMay 9, 2018Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S1 USING SCREW AND ANOTHER MANUFACTURER'S CAGE. POST-OP,THE PATIENT DEVELOPED NERVE ROOT STENOSIS DUE TO LATERAL OUT OF THE CAGE. THE CAUSE OF THE LATERAL OUT OF THE CAGE WAS THAT THE INSERTION POINT OF THE S1 SCREW WAS ON THE CRANIAL SIDE, AND THE SCREW HAD CUT OUT WHEN INSERTING IT, SO THE SCREW LOOSENED AND LATERAL OUT OF THE CAGE OCCURRED. THE PATIENT HAD ACHIEVED SOLID FUSION. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE CAGE AND REPLACEMENT OF LOOSENED SCREW. BECAUSE THE SCREW CUT OUT, THE SCREW WAS REPLACED WITH A BIGGER ONE WITH CHANGING INSERTION POINT.

  Patient problems: Stenosis

  MAUDE report 7499220 ↗