CD HORIZON® SOLERA® VOYAGER™ Spinal System 6541104Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20763000211213), received between Jun 21, 2023 and Oct 21, 2025 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION WAS PERFORMED FOLLOWING L2/5 XLIF, WITH FNS MAS USED FOR CEMENT AUGMENTATION AT L2 AND L5 FOR KYPHOSIS. IT WAS REPORTED THAT THREE MONTHS AFTER INITIAL SURGERY, THREE SET SCREWS BECAME DISLODGED ON THE LEFT SIDE OF L2 AND BOTH SIDES OF L5, RESULTING IN LOWER BACK AND LOWER LIMB PAIN AND REQUIRING REPEAT SURGERY. DURING THE REPEAT PROCEDURE, THE DISLODGED SCREWS AND RODS WERE EXPLANTED AND REPLACED, AND THE PATIENT WAS HOSPITALIZED FOR THIS INTERVENTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 23348247 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN SPINAL THERAPY FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT POST ARTHRODESIS THE ROD PLUG WAS OUT OF THE ROD AND SWIMMING IN THE BODY ON X-RAYS. THE PATIENT HAD HEADACHE AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE DEVICES. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: Headache

  MAUDE report 23053411 ↗
• MalfunctionMay 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS PEDICLE SCREW (PPS) SPINAL THERAPY FOR AN INDICATION OF DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH). IT WAS REPORTED THAT THE SET SCREW CAME OFF AND THE ROD WAS OPEN. THE SET SCREWS ON THE TOP SIDE OF BOTH SIDES ARE DISCONNECTED. 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 22016232 ↗
• InjuryMar 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SET SCREW USED FOR DEFORMITY :DEGEN THERAPY. IT WAS REPORTED THAT THE SET SCREW EXPERIENCED IMPLANT BREAKAGE. THE EQUIPMENT FAILED AT THE CONTROL AT 3 MONTHS. PATIENT EXPERIENCED RECURRENCE OF PAIN. REOPERATION WAS HAPPENED AS INTERIM MEASURE. THE PRODUCT WAS EXPLANTED AND REPLACED BY ANOTHER PRODUCT.

  Patient problems: Pain

  MAUDE report 21558350 ↗
• InjuryNov 25, 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 A PATIENT UNDERGOING POSTERIOR FIXATION FOR ROD FRACTURE AND RE-ANCHORING. LEVELS IMPLANTED AT (B)(6). IT WAS REPORTED THAT AFTER FINAL FASTENING, WHEN ATTEMPTING TO REMOVE THE PRODUCT, IT COULD NOT BE DETACHED FROM THE SCREW HEAD DESPITE THE LOCK BEING RELEASED. IT IS BELIEVED THAT THE ADJACENT EXTENDER BODY INTERFERED, LEAVING NO SPACE TO MOVE THE EXTENDER EVEN WITH THE LOCK RELEASED, CAUSING IT TO GET STUCK AND NOT DETACH. A PART OF THE TIP WAS DAMAGED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT POST-OPERATIVE INFECTION WAS CONFIRMED AFTER THE INITIAL SURGERY AND CLEANING WAS PERFORMED. THE DATE OF ONSET IS UNKNOWN; NO IMPLANT MALFUNCTIONS WERE CONFIRMED AT THIS TIME. AFTERWARDS, LEFT ROD FRACTURE, LOOSE SET SCREWS IN THE RIGHT SACRAL ILIAC, AND BACKOUT OF THE L5/S CAGE WERE CONFIRMED, AND REPEAT SURGERY WAS PERFORMED ON (B)(6) 2024. NO PATIENT SYMPTOMS ARE ASSOCIATED WITH THE MALFUNCTION. SCREW WAS ADDED FOR POSTOPERATIVE INFECTIONS. NO DEFECTS IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770102 ↗
• MalfunctionOct 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN TO EXPLANT THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20542982 ↗
• MalfunctionSep 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A PLIF PROCEDURE IN A PATIENT DIAGNOSED WITH SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THERE WAS V5 SET SCREW DISLODGEMENT. 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 20222468 ↗
• InjuryAug 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SETSCREW RE-INS TALLATION FOR LUMBAR SPASTICITY. IT WAS REPORTED THAT THERE WAS POSTOPERATIVE SET SCREW DISLODGEMENT. RE-SURGERY WAS PERFORMED ON JUL/11 AND SET SCREW WAS REPLACED. 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 19916416 ↗
• MalfunctionJul 22, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1-2A2B TRAUMA FIXATION FOR AN INDICATION OF L1 VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE V5 SET SCREW DAMAGE SUSPECTED AS WHAT APPEARED TO BE A FRAGMENT OF A SET SCREW WAS EXTRACTED FROM THE SKIN INCISION DURING WOUND CLOSURE/SURGICAL INCISION CLOSURE AFTER THE FINAL CLOSING. 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 19789680 ↗
• MalfunctionJul 22, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1-2A2B TRAUMA FIXATION FOR AN INDICATION OF L1 VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE V5 SET SCREW DAMAGE SUSPECTED AS WHAT APPEARED TO BE A FRAGMENT OF A SET SCREW WAS EXTRACTED FROM THE SKIN INCISION DURING WOUND CLOSURE/SURGICAL INCISION CLOSURE AFTER THE FINAL CLOSING. 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 19789676 ↗
• InjuryMar 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAD OLIF (L2/3/4) AND T10~SAI FIXATION AND L5/SPLIF FROM THE REAR. IT WAS REPORTED THAT THE LOOSE SCREW CAUSED INFECTION IN PATIENT. ALTHOUGH FIXATION WAS PERFORMED FROM T10 TO SAI, A WOUND APPEARED ON THE SKIN OF THE RIGHT SAI AREA AND PUS ALSO CAME OUT. WHEN IT WAS DEPLOYED, THE TISSUE FROM THE SKIN SURFACE TO THE SCREW HEAD CONTINUED TO HAVE DARK GRANULATION, AND THERE WAS PUS IN THE SURROUNDING AREA. THE SET SCREW IN THE SCREW HEAD WAS LOOSE ENOUGH THAT IT COULD BE REMOVED WITH FORCEPS, AND THE SURROUNDING TISSUE SHOWED DARK SPOTS AND BLACK POWDERY MATTER. THE SCREW THAT HAD BEEN INSERTED HAD A CLEAR ZONE ON THE IMAGE, BUT IT WAS REASONABLY EFFECTIVE. THE RIGHT SIDE WAS IN A NOTICEABLE CONDITION, BUT WHEN CHECKED THE LEFT SIDE, IT WAS IN THE SAME CONDITION. A REVISION SURGERY WAS PERFORMED DUE TO SUSPICION OF METALLOSIS DUE TO WEAR PARTICLES OF THE IMPLANT, BLACK GRANULATION ON THE SOFT TISSUES, WOUNDS ON THE WOUND SURFACE AND PUS IN THE VICINITY. IMPLANT WAS CUT AND REMOVED. INITIAL SURGERY WAS DONE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED. THE SET SCREWS WERE L

  Patient problems: Foreign Body Reaction; Post Operative Wound Infection

  MAUDE report 18984840 ↗
• InjuryMar 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAD OLIF (L2/3/4) AND T10~SAI FIXATION AND L5/SPLIF FROM THE REAR. IT WAS REPORTED THAT THE LOOSE SCREW CAUSED INFECTION IN PATIENT. ALTHOUGH FIXATION WAS PERFORMED FROM T10 TO SAI, A WOUND APPEARED ON THE SKIN OF THE RIGHT SAI AREA AND PUS ALSO CAME OUT. WHEN IT WAS DEPLOYED, THE TISSUE FROM THE SKIN SURFACE TO THE SCREW HEAD CONTINUED TO HAVE DARK GRANULATION, AND THERE WAS PUS IN THE SURROUNDING AREA. THE SET SCREW IN THE SCREW HEAD WAS LOOSE ENOUGH THAT IT COULD BE REMOVED WITH FORCEPS, AND THE SURROUNDING TISSUE SHOWED DARK SPOTS AND BLACK POWDERY MATTER. THE SCREW THAT HAD BEEN INSERTED HAD A CLEAR ZONE ON THE IMAGE, BUT IT WAS REASONABLY EFFECTIVE. THE RIGHT SIDE WAS IN A NOTICEABLE CONDITION, BUT WHEN CHECKED THE LEFT SIDE, IT WAS IN THE SAME CONDITION. A REVISION SURGERY WAS PERFORMED DUE TO SUSPICION OF METALLOSIS DUE TO WEAR PARTICLES OF THE IMPLANT, BLACK GRANULATION ON THE SOFT TISSUES, WOUNDS ON THE WOUND SURFACE AND PUS IN THE VICINITY. IMPLANT WAS CUT AND REMOVED. INITIAL SURGERY WAS DONE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED. THE SET SCREWS WERE L

  Patient problems: Foreign Body Reaction; Post Operative Wound Infection

  MAUDE report 18984830 ↗
• InjuryDec 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR RUPTURE FRACTURE. PROCEDURE PERFORMED WAS 1-1 FIXATION FOR RUPTURE FRACTURES. IT WAS REPORTED THAT THE V5 SET SCREW DISLODGE. A SCREW WAS INSERTED INTO THE AFFECTED VERTEBRAE ON ONE SIDE. PS WAS ALSO INSERTED INTO THE AFFECTED VERTEBRAE ON ONE SIDE. SET SCREW OF THE MOST CAUDAL SIDE PS DISLODGED (ON THE SIDE THAT DOES NOT HAVE AFFECTED VERTEBRAL PS). THE PROCEDURE WAS PERFORMED TO REMOVE THE NAIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS PERFORMED BECAUSE BONE FUSION WAS COMPLETED AND HAD DISLODGEMENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407574 ↗
• InjuryNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED SETSCREW. PRE-OP DIAGNOSIS OF PATIENT INCLUDE POSTERIOR SCOLIOSIS. IT WAS REPORTED THAT, V5 SET SCREW DISLODGEMENT. THE INSERTED SCREW OF THE SET SCREW IN SACRO-ALAR-ILIAC REGION WAS DISLODGED. REVISION SURGERY WAS PERFORMED AND THE DISLODGED SETSCREW WAS EXPLANTED. PROCEDURE OR TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS OBLIQUE LUMBAR INTERBODY FUSION AND POSTERIOR FIXATION. THE LEVELS IMPLANTED WERE THORACIC 10 TO SACRAL-ALAR-ILIAC. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18045493 ↗
• MalfunctionOct 27, 2023Failure to Align; Failure to Align

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION FOR BURST FRACTURE OF THE SECOND LUMBAR VERTEBRA. IT WAS REPORTED THAT THE SET SCREW WAS CROSS-THREADED DURING THE FASTENING, SO THE FINAL FASTENING COULD NOT BE PERFORMED AS IT WAS. 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 18019691 ↗
• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4 SET SCREW RE PLACEMENT FOR AN INDICATION OF INADEQUATE BONE FUSION AFTER POSTERIOR FUSION. IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY OF POSTERIOR FIXATION BY L3 / 4DEPS TECHNIQUE AND POSTERIOR FIXATION BY S1 / S2AI AND REVISION SURGERY WAS PERFORMED DUE TO BONE FUSION FAILURE AFTER POSTERIOR FIXATION. THERE WAS NO MALFUNCTION WITH MDT PRODUCTS THAT RESULTED IN BONE FUSION FAILURE. DURING REVISION SURGERY, WHILE THE SET SCREW WAS ABOUT TO BE INSTALLED, IT WAS HARD LIKE A CROSS-THREAD, AND THE SET SCREW WAS REPLACED WITH A NEW ONE, BUT NO IMPROVEMENT. IT APPEARED THAT THE SCREW HEAD THREAD ITSELF MAY HAVE BEEN DEFORMED, AND WHEN THE SCREW WAS REPLACED AND THE SET SCREW WAS REPLACED AGAIN WITH ANOTHER ONE, THE PROBLEM WAS RESOLVED. WHILE THE SET SCREW IS A TITANIUM ALLOY, IT IS UNLIKELY THAT THE THREAD OF THE COBALT-CHROME ALLOY SCREW HEAD WAS PUSHED DOWN AND CRUSHED, BUT IT IS UNCLEAR WHETHER THE PROBLEM WAS ON THE SET SCREW OR THE SCREW. 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 17237177 ↗
• MalfunctionJun 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW AND SET SCREW IN AN L4/5 VERTEBRA TLIF FOR L4/5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER THE INCISION CLOSURE, SOMETHING LIKE A NEEDLE WAS STUCK INTO THE HAND. WHEN CHECKING BY PALPATION AFTER THREAD CUTTING AND TAB FOLDING, THE BURR OF THE SET SCREW OR THE SCREW HEAD MAY HAVE BEEN STUCK ON THE GLOVES. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169308 ↗