CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015540Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169783768), received between Oct 14, 2019 and Apr 22, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. SURGERY WAS PERFORMED FOR LCS WITHOUT L5 RADICULAR SYMPTOMS. SCREW WAS INSERTED USING MAZOR AND THE SCREW DEVIATED INTO THE SPINAL CANAL AND RADICULAR SYMPTOMS OCCURRED. RE-OPERATION OCCURRED AND IT WAS RE-INSERTED BY FREEHAND. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21880710 ↗
• InjuryApr 22, 2025Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. SURGERY WAS PERFORMED FOR LCS WITHOUT L5 RADICULAR SYMPTOMS. SCREW WAS INSERTED USING MAZOR AND THE SCREW DEVIATED INTO THE SPINAL CANAL AND RADICULAR SYMPTOMS OCCURRED. RE-OPERATION OCCURRED AND IT WAS RE-INSERTED BY FREEHAND. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21880700 ↗
• InjuryApr 22, 2025Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. SURGERY WAS PERFORMED FOR LCS WITHOUT L5 RADICULAR SYMPTOMS. SCREW WAS INSERTED USING MAZOR AND THE SCREW DEVIATED INTO THE SPINAL CANAL AND RADICULAR SYMPTOMS OCCURRED. RE-OPERATION OCCURRED AND IT WAS RE-INSERTED BY FREEHAND. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21880673 ↗
• InjuryMar 28, 2025Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/S2 SPINAL TH ERAPY FOR AN INDICATION OF LUMBAR CANAL STENOSIS (LCS). IT WAS REPORTED THAT THERE WAS S2SCREW MISALIGNMENT. THE SCREW WAS INSERTED ACCORDING TO THE PLAN USING THE MAZOR SYSTEM AND POSTOPERATIVE CT CONFIRMED THAT THE S2 SCREW WAS INSERTED ALONG THE SACROILIAC JOINT, WITH THE SCREW THREADS PROTRUDING INTO THE PELVIS. THE PATIENT PRESENTED NEUROLOGICAL SYMPTOMS AND THE ATTENDING PHYSICIAN'S OPINION IS THAT THE PATIENT'S POSTOPERATIVE NEUROLOGICAL SYMPTOMS ARE LIKELY DUE TO THE DEVIATION OF THE L5 SCREW WHICH WAS INSERTED FREEHAND BECAUSE THE MAZOR SYSTEM COULD NOT BE USED. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED IN OVERALL PROCEDURE TIME. THERE WAS EXTENSION OF EXISTING HOSPITALIZATION AS A RESULT OF THE EVENT AND THE PATIENT WAS SCHEDULED FOR REPEAT SURGERY ON (B)(6) 2025 FOR SCREW REPLACEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21716558 ↗
• InjuryJun 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A FUNNEL USED IN AN L4/5 CAGE REPLACEMENT REOPERATION (L4-S PPS, L4/5 TLIF, 5/S TLIF) FOR LCS, LEG PARALYSIS, AND NUMBNESS. IT WAS REPORTED THAT THE BONE GRAFT FUNNEL WAS FILLED WITH BONE IN AN ATTEMPT TO FILL THE INTERVERTEBRAL DISC WITH BONE GRAFT, BUT GOT STUCK AND WOULD NOT COME OUT. AFTER ATTEMPTS TO REMOVE THE BLOCKAGE WITH STEEL OBJECTS FROM THE HOSPITAL, THE PROBLEM PERSISTED AND THEREFORE WAS IDENTIFIED AS A FAILURE EVENT. THE FUNNEL WAS NOT USED ON THE PATIENT, EVEN THOUGH THE PATIENT WAS ON THE OPERATING TABLE WHEN THE MALFUNCTION OCCURRED. THERE WAS NO PATIENT IMPACT. THE L4/5 CAGE BACKED OUT DUE TO A SCREW LOOSENING ON THE RIGHT SIDE OF L4. THIS WAS A REPEAT SURGERY DUE TO SCREW LOOSENING AND CAGE BACK OUT. THE DATE OF INITIAL SURGERY WAS ON (B)(6) 2023. ON (B)(6) 2023, REPEAT SURGERY WAS PERFORMED. THE RIGHT L4 SCREW AND THE L4/5 CAGE WERE REMOVED AND REPLACED WITH A NEW ONE. THE CAUSE OF SCREW LOOSENING WAS THAT THE L4 RIGHT SCREW WAS PLACED OUTWARD FROM THE PEDICLE AND DEVIATED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036362 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCREW REMOVAL SURGERY AT L2 DUE TO BONE UNION HAD ACHIEVED. INTRA-OP, SCREW ON THE LEFT SIDE OF L2 HAD BROKEN DURING REMOVING THE SCREW AS THE BONE UNION ACHIEVED. FRAGMENTS OF THE IMPLANT WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213161 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L4 VERTEBRAL REPLACEMENT AND POSTERIOR FIXATION AT L2-S1. ON AN UNKNOWN DATE, POST-OP, THERE WAS A CLEAR ZONE AT L2 RIGHT SCREW PART AND INFECTION WAS REPORTED AT THAT SITE. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE SCREW WAS COMPLETELY EXPLANTED. THE INFECTED SITE WAS WASHED; AND A HOOK WAS PLACED. THEN, WOUND CLOSURE WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 9187963 ↗