CD HORIZON® SOLERA® VOYAGER™ Spinal System NAV6550005Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00643169754522), received between Mar 29, 2019 and Feb 26, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Break” (57 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TWO DRIVERS HAD A BROKEN TIP, AND THE OTHER HAD A WARPED TIP. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE/THERAPY INVOLVED WAS REMOVAL EXTENSION POSTERIOR FUSION FOR ADJACENT LEVEL DISC DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451969 ↗
• MalfunctionFeb 12, 2026Break

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT A NAVIGATED VOYAGER DRIVER WAS FOUND IN THE STERILE PROCESSING DEPARTMENT WITH ITS DISTAL TIP BROKEN OFF. 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 24329681 ↗
• MalfunctionFeb 5, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE DRIVER'S TIP WAS BENT AND THE FLEX ARM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266483 ↗
• MalfunctionSep 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF WHILE ADVANCING THE SCREW. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE/THERAPY INVOLVED WAS MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION, AND THE INSTRUMENT BROKE WHILE ADVANCING THE S1 SCREW. HOWEVER, NOTHING WAS RETAINED IN THE PATIENT AND A BACK UP DRIVER WAS AVAILABLE SO THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT WAS TREATED FOR L5-S1 SPONDYLOLISTHESIS AND FORAMINAL STENOSIS. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048855 ↗
• MalfunctionSep 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE NAV SCREWDRIVER WAS BROKEN, THE SCREW CADDY LID WAS BENT AND WILL NOT SLIDE ONTO A CADDY, THE RATCHETING HANDLE NO LONGER RATCHETS AND THE INFINITY DRIVER WAS STRIPPED. 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 22990427 ↗
• MalfunctionAug 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DRIVER BROKE DURING SCREW INSERTION. 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 22719126 ↗
• MalfunctionJun 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS 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 22316063 ↗
• MalfunctionJun 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS 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 22315643 ↗
• MalfunctionJun 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, WHILE TRYING TO ADJUST THE HEIGHT OF THE 5.5 VOYAGER SCREW, THE TIP OF THE SCREW DRIVER SNAPPED OFF. THE DRIVER WAS PASSED OFF THE STERILE FIELD AND THE PIECE OF DRIVER THAT REMAINED WAS DISCARDED. PROCEDURE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION L2-3/MINIMALLY INVASIVE SURGERY - TRANSFORAMINAL LUMBAR INTERBODY FUSION L5-S1/REVISION OF HARDWARE L3-5/MINIMALLY INVASIVE SURGERY POSTERIOR LUMBAR FUSION L2-S1. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296129 ↗
• MalfunctionJun 19, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE T25 THAT ARTICULATES WITH THE SCREW HEAD ON THE DRIVER SEEMS TO HAVE BROKEN OFF, SO THE SCREWDRIVER CAN ONLY THREAD INTO THE SCREW TABS BUT NOT ACTUALLY SIT IN THE SCREW HEAD. THIS WOULD PROBABLY BE DANGEROUS TO USE SINCE THE SCREWS ARE NOT ABLE TO LOCK INTO THE DRIVER. 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 22294631 ↗
• MalfunctionMay 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVAS IVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT WHILE PUTTING SCREW IN, WAS HARD BONE. LAST TURN OF DRIVER THE TIP OF THE DRIVER SNAPPED OFF IN THE SCREW. ALTHOUGH DIFFICULT, THE TIP WAS FINALLY REMOVED FROM THE SCREW. IT APPEARED TO BE "COLD WELDED" IN THE SCREW. THERE WERE NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT, THEY WERE ABLE TO RETRIEVE THE BROKEN ¿TIP¿. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103749 ↗
• MalfunctionMay 29, 2025Break; Degraded; Break; Degraded

  THE PRODUCTS WERE PREVIOUSLY USED WITHOUT ISSUE BUT APPEAR TO HAVE WORN DOWN OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103603 ↗
• MalfunctionApr 27, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER HAD A BROKEN TIP. THE PRODUCT WAS NOT ASSOCIATED WITH ANY EVENT AND BROKE BEFORE USAGE. 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 21915919 ↗
• MalfunctionApr 27, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER HAD A BROKEN TIP. THE PRODUCT WAS NOT ASSOCIATED WITH ANY EVENT AND BROKE BEFORE USAGE. 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 21915918 ↗
• MalfunctionMar 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT WHILE PUTTING IN S1 SCREWS, TIP SHEARED OFF IN THE SCREW HEAD. FISHED BOTH TIPS OUT AND FINISHED THE CASE. 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 21684891 ↗
• MalfunctionMar 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT WHILE PUTTING IN S1 SCREWS, TIP SHEARED OFF IN THE SCREW HEAD. FISHED BOTH TIPS OUT AND FINISHED THE CASE. 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 21684888 ↗
• MalfunctionMar 20, 2025Break; Break

  INFORMATION WAS RECEIVED VIA USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT PIECE OF DEVICE HAS BROKEN. THE PATIENT INVOLVEMENT IN THE EVENT IS UNKNOWN AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650216 ↗
• MalfunctionFeb 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR POSTERIOR SPINAL FUSION (PSF) AT LEVELS L4-S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS POSTERIOR SPINAL FUSION (PSF). IT WAS REPORTED THAT WHILE PLACING THE VOYAGER ILIAC SCREWS, THE NAV DRIVER TIP SNAPPED OFF AND SUBSEQUENT ATTEMPTS TO ADVANCE THE SCREW WITH OTHER DRIVERS AND INSTRUMENTS ALSO RESULTED IN BREAKAGE. AND THE END OF THE HEAD TURNER DRIVER WAS MORPHED. THE SCREW WAS REMOVED AND REPLACED WITH ONE OF A SMALLER DIAMETER. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467577 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER USED IN AN UNKNOWNS SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER TIP BROKE IN THE HEX OF THE TULIP HEAD. THE ROD WAS PLACED ON TOP, THEN A SET SCREW. THE TIP WOULD NOT BE MOVED FROM THE SPOT IT WAS BROKEN. NO RISK TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21456848 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE DRIVER BROKEN WHEN ATTEMPTING TO REMOVE HARDWARE FROM A PATIENT USING MINIMALLY IN VASIVE TECHNIQUE. PIECES OF THE BROKEN DRIVER WERE REMOVED FROM THE PATIENT. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS A REVISION TLIF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362343 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING POST OP. IT WAS R REPORTED THAT DRIVERS WERE BROKEN POST OPERATIVELY. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362133 ↗
• MalfunctionFeb 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION SURGERY. IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE DURING SCREW INSERTION. 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 21330065 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS FOUND TO HAVE BROKEN TIP SHEARED OFF. WAS FOUND BEFORE SURGERY AND NOT USED IN THE SURGERY. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301048 ↗
• MalfunctionFeb 3, 2025Degraded; Degraded

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THREADS OF THE DRIVER WERE WORN. 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 21291243 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP GOT BROKE OFF. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE MANY TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290135 ↗