CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00643169754584), received between Nov 19, 2019 and Sep 28, 2026 — classified as 3 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (87 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Mechanical Problem

  Information was received from multiple sources (Manufacturer Representative, User Facility, Other) regarding a Tab Extender used for thoracolumbar spine fixation therapy. It was reported that the tab extender was loose when checked with the cap attached. 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 50911075 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894115 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894092 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894029 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894024 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894023 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50893989 ↗
• MalfunctionSep 25, 2026Corroded

  Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50893983 ↗
• MalfunctionSep 11, 2026Material Twisted/Bent

  Information was received from health care provider via manufacturing representative regarding a product identified during an event. It was reported that extender was bent. Preoperative diagnosis for this surgery L1, L3 burst fracture. No patient symptoms were reported. No further complications were reported/anticipated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734205 ↗
• MalfunctionSep 9, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50687226 ↗
• MalfunctionSep 9, 2026Material Twisted/Bent

  Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681908 ↗
• MalfunctionSep 9, 2026Material Twisted/Bent

  Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681902 ↗
• MalfunctionSep 9, 2026Material Twisted/Bent

  Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681860 ↗
• MalfunctionSep 9, 2026Material Twisted/Bent

  Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681856 ↗
• MalfunctionAug 31, 2026Material Twisted/Bent; Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519540 ↗
• MalfunctionAug 28, 2026Product Quality Problem; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492760 ↗
• MalfunctionAug 28, 2026Device Damaged by Another Device

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having replacement Spi nal therapy to L5 for Compression fracture. It was reported that Cement leaked from the screw head for only 1 of the 4 screws. There were no patient symptoms reported. There were no further complications reported regarding the event. Additional information received from the manufacturer representative that the Leakage due to the connection between the screw and the T25 guide. There was no malfunction with the cement and T25 driver reported in this event. Additional information received from the manufacturer representative that the products arrived at Japan QA still attached. Cement adhesion was observed on the distal side of the products. No breakage or other damage was observed for PLI 40 to 70.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491265 ↗
• MalfunctionAug 28, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491256 ↗
• MalfunctionApr 19, 2026Material Deformation; Material Twisted/Bent

  INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT A SCREW WAS ATTEMPTED TO BE IMPLANTED, BUT THE HANDLE BROKE INTO TWO PIECES, THE TIPS OF THE TAB EXTENSION HAVE BENT AND WILL NOT ATTACH TO THE RING CONNECTION PIECE AND THE DRIVER WAS STRIPPED AND WILL NOT PROPERLY ENGAGE WITH A SCREW. A REMOVAL BIT WAS PLACED INTO EXTENSION ATTACHMENT THEN A SCREW WAS ATTEMPTED TO BE EXPLANTED, AND THE DRILL BIT SUBSEQUENTLY CAME OUT OF THE EXTENSION PIECE. WHILE ANOTHER SCREW WAS ATTEMPTED TO BE IMPLANTED, ANOTHER HANDLE STOPPED RATCHETING. THERE WERE NO PATIENT SYMPTOMS INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921056 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER AND EXTENDERS. IT WAS REPORTED THAT DRIVER WON'T HOLD SHANK AND EXTENDERS ARE BENT. 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 24256249 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER AND EXTENDERS. IT WAS REPORTED THAT DRIVER WON'T HOLD SHANK AND EXTENDERS ARE BENT. 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 24256236 ↗
• MalfunctionJan 20, 2026Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR TH12 DISH. IT WAS REPORTED THAT DURING THE FINAL TAB BREAKING AFTER V5 WAS FULLY TIGHTENED, FORCE WAS APPLIED TO BREAK THE TAB BEFORE THE TAB BREAKER WAS FULLY INSERTED, RESULTING IN THE TAB BECOMING BENT. 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 24113193 ↗
• MalfunctionJan 6, 2026Material Deformation; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE POSTERIOR LUMBAR INTERBODY FUSION (PLIF). IT WAS REPORTED THAT EXTENDER TAB WAS STUCK AND DAMAGED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972744 ↗
• MalfunctionDec 31, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE EXTENDER WAS BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932237 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L2-L5 OLIF+PPS PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT ON THE DAY AFTER SURGERY, THE DISTRIBUTOR NOTIFIED THAT DEFORMATION OF THE TAB WAS OBSERVED WHEN THE INSTRUMENT WAS RETRIEVED FOR RETURN AND THE MOVEMENT OF THE JOINT IN THE ANTERIOR RACK MOUNT WAS LESS SMOOTH (STIFFER) THAN USUAL. 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 23921353 ↗