CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169768284), received between Mar 23, 2021 and Jul 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST L4/5 PERC SCREWS/MIDLINE INCISION FOR INTERBODY IN A PATIENT DIAGNOSED WITH BACK AND LEG PAIN . IT WAS REPORTED THAT PATIENT PRESENTED FOR FOLLOW-UP COMPLAINING OF LEG PAIN. RESCANNED AND CAGE SHOWN TO HAVE BACKED OUT INTO CANAL. ON CT THE SCREWS HAVE ALSO OBSERVED TO HAVE LUCENCY AROUND THEM. SCREWS LOOSENED DUE TO THE LACK OF ANTERIOR COLUMN SUPPORT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19699709 ↗
• InjuryJul 18, 2022Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST OP OF THE REPO RTED PRODUCTS. IT WAS REPORTED THAT, SCREW HEAD WITH FEW THREADS LENGTH OF THE SHAFT HAS BEEN EXPLANTED. THE REST OF THE SHAFT HAS BEEN LEFT IN THE PATIENT. THE PROCEDURE INVOLVED WAS REVISION SURGERY TO REPLACE THE SCREW, AND INITIAL PROCEDURE PERFORMED WAS MIS L5/S1 INSTRUMENTED FUSION WITH RIGHT SIDED TLIF. THE LEVELS IMPLANTED DURING INITIAL SURGERY WAS LEFT S1. IT WAS UNKNOWN ABOUT THE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15037700 ↗
• InjuryJul 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A PERCUTANEOUS PSF AT T10-L2. IT WAS REPORTED THAT THE SCREWS MALFUNCTIONED SOMETIME BETWEEN IMPLANT AND REMOVAL, LIKELY DURING ONE OF THE PATIENT'S FALLS. UPON EXPLANTATION, THE HCP NOTICED THAT THE SCREWS TULIPS WERE WELDED TO THE SHANK IN A WAY THAT THE POLY AXIAL RANGE OF MOTION WAS LOST AND THE TULIP WAS ¿FIXATED¿ AT A DIFFERENT DEGREE FOR EACH OF THE RESPECTIVE SCREWS. THE SURGEON WAS UNABLE TO PUT THE SHANK OF THE DRIVER THROUGH THE TULIP TO SEAT IT INSIDE OF THE SCREW SHANK BECAUSE THE FIXATED TULIP WAS BLOCKING A STRAIGHT PATH WAY FOR THE DRIVER TO SEAT. THE MALFUNCTIONING OF THE SCREWS WAS LIKELY DUE TO A FALL. THE PATIENT IS OSTEOPOROTIC AND THE SCREWS WERE HALOING SEVERELY AND LOOSE. THE PATIENT HAS HAD MULTIPLE FALLS. THE HCP DETERMINED THAT THE SCREWS DID NOT STABILIZE THE PATIENT AS HE HAD HOPED. THE SURGEON DECIDED TO REMOVE HARDWARE AS PART OF HER PREVENTATIVE TREATMENT PLAN AND AT THE TIME OF THE HARDWARE REMOVAL, HE NOTICED THE SCREW MALFUNCTION. THERE IS NO INJURY TO THE PATIENT DUE TO THE SCREW MALFUNCTION. THE DATE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913679 ↗
• InjuryJul 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A PERCUTANEOUS PSF AT T10-L2. IT WAS REPORTED THAT THE SCREWS MALFUNCTIONED SOMETIME BETWEEN IMPLANT AND REMOVAL, LIKELY DURING ONE OF THE PATIENT'S FALLS. UPON EXPLANTATION, THE HCP NOTICED THAT THE SCREWS TULIPS WERE WELDED TO THE SHANK IN A WAY THAT THE POLY AXIAL RANGE OF MOTION WAS LOST AND THE TULIP WAS ¿FIXATED¿ AT A DIFFERENT DEGREE FOR EACH OF THE RESPECTIVE SCREWS. THE SURGEON WAS UNABLE TO PUT THE SHANK OF THE DRIVER THROUGH THE TULIP TO SEAT IT INSIDE OF THE SCREW SHANK BECAUSE THE FIXATED TULIP WAS BLOCKING A STRAIGHT PATH WAY FOR THE DRIVER TO SEAT. THE MALFUNCTIONING OF THE SCREWS WAS LIKELY DUE TO A FALL. THE PATIENT IS OSTEOPOROTIC AND THE SCREWS WERE HALOING SEVERELY AND LOOSE. THE PATIENT HAS HAD MULTIPLE FALLS. THE HCP DETERMINED THAT THE SCREWS DID NOT STABILIZE THE PATIENT AS HE HAD HOPED. THE SURGEON DECIDED TO REMOVE HARDWARE AS PART OF HER PREVENTATIVE TREATMENT PLAN AND AT THE TIME OF THE HARDWARE REMOVAL, HE NOTICED THE SCREW MALFUNCTION. THERE IS NO INJURY TO THE PATIENT DUE TO THE SCREW MALFUNCTION. THE DATE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913674 ↗
• InjuryMar 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- PAINFUL ORTH OPEDIC HARDWARE AFTER PROCEDURE INVOLVED IN MINIMALLY INVASIVE TECHNIQUES FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). LEVELS IMPLANTED- L5-S1. IT WAS REPORTED THAT DURING USE, THE PATIENT HEARD A POP IN THEIR BACK. REPORTED THE BREAKAGE WAS DUE TO THE WEIGHT OF THE PATIENT. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. REVISION SURGERY WAS PERFORMED TO EXPLANT THE PRODUCT, AS PATIENT HAD INCREASE BACK PAIN BECAUSE OF THE BROKEN SCREW. THERE WERE NO BROKEN FRAGMENTS LEFT IN THE PATIENT BODY. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. AFTER REVISION SURGERY, PATIENT IS RECOVERING. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: Pain

  MAUDE report 11553695 ↗