CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169783843), received between Feb 2, 2020 and Oct 10, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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.

• InjuryOct 10, 2023Device 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 REVISION SURGERY DUE TO LOWER BACK PAIN, DUE TO THE LOOSENESS OF THE L5 SCREW, THERE WAS CONCERN ABOUT INTERVERTEBRAL INSTABILITY AT L4/5 AFTER THE INITIAL L4/5 OLIF PROCEDURE. IT WAS REPORTED THAT AFTER REMOVING THE LEFT L4 SCREW, THE REPORTED PRODUCT SV56 CNMAS 7.5X50 WAS ATTACHED TO THE RETAINING SCREWDRIVER AND INSERTED. THE TORQUE WAS APPLIED DURING THE INSERTION OF THE PPS AND THE TIP PORTION OF THE RETAINING SCREWDRIVER WAS BROKEN AND REMAINS IN THE SV56 CNMAS 7.5X50. THE CUT ROD WAS FINALLY TIGHTENED AND THE SV56 CNMAS 7.5X50 WAS REMOVED. LOOSENING WAS OBSERVED IN THE TWO SCREWS ON THE LEFT AND RIGHT SIDES OF L5. RELATIONSHIP BETWEEN "LOWER BACK PAIN" AND "LOOSENING OF THE L5 SCREW" IS UNKNOWN. THE PHYSICIAN BELIEVED THAT THE L5 LOOSENING OCCURRED AND A FINE MOVEMENT MIGHT REMAIN IN BETWEEN THE VERTEBRAE ON L4/5. THE LOOSENED L5 SCREW WAS REMOVED DURING REPEAT SURGERY AND REPLACED WITH MEDTRONIC PRODUCT. FRAGMENT OF THE SCREWDRIVER TIP REMAINED IN THE CORE OF THE SCREW. IT BECAME DIFFICULT TO REMOVE. IN THE END, IT WAS REMOVED. THERE WERE NO F

  Patient problems: Pain

  MAUDE report 17902458 ↗
• InjuryFeb 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- L3/4/5 LUMBAR SPINAL CANAL STENOSIS INVOLVED IN THE OLIF (OBLIQUE LATERAL INTERBODY FUSION) AND VOYAGER5.5 / 6.0 PROCEDURE. LEVELS IMPLANTED- L3/4/5. IT WAS REPORTED THAT POST-OPERATIVELY, AFTER INSERTING THE SCREW AND ROD, REOPERATION WAS PERFORMED BECAUSE THE SCREW BECAME LOOSE, AND THE SET SCREW CAME OFF. AFTER THAT, THE LOOSENESS OF THE SET SCREW WAS CONFIRMED AGAIN, SO OPERATION WAS PERFORMED AGAIN ON THE REPORTED DAY. L3/4/5 OLIF AND POSTERIOR PPS FIXATION. RE-OPERATION WAS PERFORMED BECAUSE THE SCREW ON THE RIGHT SIDE OF L4 WAS LOOSE AND THE SET SCREW OF L5 CAME OFF. PATIENT WAS HOSPITALIZED PROLONG DUE TO RE-OPERATION. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2022-FEB-02, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO IMPACT ON THE PATIENT. ON 2022-FEB-07, RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER AND THE PRODUCT NUMBER ARE DIFFERENT FOR THE L4 SCREW AND THE L5 SET SCREW. THE PRODUCT USED AT THE TIME OF THE INITIAL OPERATION WAS ALSO VOYAGER 5.5 / 6.0, AND AFTER THE INITIAL SURGERY, THE SCREW ON THE RIGHTL4 WAS LOOSENED AND THE SET SCR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589939 ↗
• InjuryFeb 7, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PEDICLE SCREW PLACEMENT AT L2-L3, CROSSLINK PLACEMENT WAS PERFORMED AT S1, SCREW INSERTION WAS PERFORMED AT S2AI AND RODS WERE INSERTED ON BOTH SIDES. ON AN UNKNOWN DATE, POST-OP, THE SCREW BACKED-OUT AT RIGHT SIDE OF L3. ALONG WITH THE ALLEGED SCREW, THE SCREW AT RIGHT SIDE OF L2 BACKED-OUT; AND LEFT SIDE OF THE CROSSLINK AT S1-S2AI DEVIATED (BACKED-OUT) FROM SACRUM. HENCE, A REVISION SURGERY, WAS PERFORMED, IN WHICH, THE BACKED-OUT CROSSLINK WAS EXPLANTED AND WAS REPLACED WITH A NEW ONE. THE BACKED-OUT SCREWS WERE REMOVED; AND WERE REPLACED WITH SCREWS OF BIGGER SIZE, WITH CHANGE IN INSERTION ANGLE. ROD PLACEMENT WAS PERFORMED AGAIN. ADDITIONAL CROSSLINK PLACEMENT WAS PERFORMED BETWEEN L2-L3. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9682383 ↗
• InjuryFeb 7, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PEDICLE SCREW PLACEMENT AT L2-L3, CROSSLINK PLACEMENT WAS PERFORMED AT S1, SCREW INSERTION WAS PERFORMED AT S2AI AND RODS WERE INSERTED ON BOTH SIDES. ON AN UNKNOWN DATE, POST-OP, THE SCREW BACKED-OUT AT RIGHT SIDE OF L2. ALONG WITH THE ALLEGED SCREW, THE SCREW AT RIGHT SIDE OF L3 BACKED-OUT; AND LEFT SIDE OF THE CROSSLINK AT S1-S2AI DEVIATED (BACKED-OUT) FROM SACRUM. HENCE, A REVISION SURGERY, WAS PERFORMED, IN WHICH, THE BACKED-OUT CROSSLINK WAS EXPLANTED AND WAS REPLACED WITH A NEW ONE. THE BACKED-OUT SCREWS WERE REMOVED; AND WERE REPLACED WITH SCREWS OF BIGGER SIZE, WITH CHANGE IN INSERTION ANGLE. ROD PLACEMENT WAS PERFORMED AGAIN. ADDITIONAL CROSSLINK PLACEMENT WAS PERFORMED BETWEEN L2-L3. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9682314 ↗
• InjuryFeb 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L5-S1. AT L5 RIGHT, S1 RIGHT AND S1 LEFT, SCREWS OF DIMENSION 6.5MM X 45MM WERE INSERTED. AT L5 LEFT, 7.5MM X 45MM SCREW WAS INSERTED. 40 MM ROD WAS INSERTED ON THE RIGHT SIDE AND 45 MM ROD WAS INSERTED ON THE LEFT SIDE. TWO CAGES WERE INSERTED DURING THIS SURGERY. ON AN UNKNOWN DATE, POST-OP, SCREW ON THE RIGHT SIDE OF S1 BROKE AT THE SHAFT (ABOUT 1 CM BELOW THE SCREW HEAD). THE PATIENT ALSO COMPLAINED OF PAIN, WHICH SUDDENLY OCCURRED ON (B)(6) 2019. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY FOR REMOVING THE BROKEN SCREW. THE BROKEN SCREW ALONG WITH ALL THE OTHER SCREWS WAS COMPLETELY REPLACED. MOREOVER, ONE MORE CAGE WAS INSERTED AT THE RIGHT SIDE. THERE IS NO INFORMATION ON WHETHER THE BONES WERE FUSED. THE SURGEON CONSIDERED THAT SCREW MIGHT HAVE BROKEN DUE TO THE LOAD ON THE RIGHT SIDE BECAUSE THE CAGES THAT WERE INSERTED BEFORE HAD NOT BEEN INSERTED TO THE MIDDLE. WHEN THE EXPLANTED SCREW WAS EXAMINED, THE SCREW WAS FOUND BROKEN AT ABOUT 42 MM FROM THE TIP. ON FRONT AND BEHIND, THE THREADS WERE DAMAGED, RUBBED AT THE CROWN, AND SCRATCHES WERE FOUND ON THE SCREW HEAD THREADS AND THE EDGES OF

  Patient problems: Pain

  MAUDE report 9656912 ↗