CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169783904), received between Jan 20, 2020 and May 21, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• InjuryMay 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS AT L3-S1; AND UNDERWENT PERCUTANEOUS PEDICLE SCREW FIXATION AND POSTERIOR LUMBAR INTERBODY FUSION AT L3-L5, AND TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1. ABOUT HALF A YEAR, POST-OP, PARTIAL BONE UNION FAILURE OCCURRED AT L3-L4 AND L4-L5; AND GENERAL LOOSENING OF THE PEDICLE SCREW OCCURRED. IT WAS JUDGED THAT THIS EVENT WAS NOT BECAUSE OF THE ALLEGED PRODUCT BUT DUE TO THE CHARACTERISTICS OF THE DISEASE (INVOLUNTARY MOVEMENTS) AND THE EFFECTS OF OSTEOPOROSIS. BONE UNION WAS ACHIEVED AT L5-S1. THE PATIENT ALSO EXPERIENCED LUMBAR BACKACHE. A REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2020; BUT IT IS UNKNOWN IF THIS SURGERY HAS BEEN PERFORMED OR NOT. PEDICLE SCREW REPLACEMENT WAS PLANNED DURING THIS SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10079700 ↗
• InjuryMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4-L5 DUE TO GRADE 2 SPONDYLOLISTHESIS AT L4. INTRA-OP, WHEN CHECKING THE FRONTAL IMAGE AFTER FINAL TIGHTENING, IT WAS FOUND THAT THE SCREW ON THE LEFT SIDE OF L4 CAME OFF TO THE LATERAL SIDE. AFTER SCREW INSERTION, IT WAS CHECKED THAT THE SCREW HAD ENTERED THE VERTEBRAL BODY; HENCE, THE SURGEON CONSIDERED THAT THERE WAS A HIGH POSSIBILITY THAT THE PEDICLE HAD FRACTURED DURING COMPRESSION OR FINAL TIGHTENING. IT WAS SUSPECTED THAT BONE FRACTURE HAD OCCURRED SINCE THE STATE WAS UNSTABLE. THEN, THE IMPLANTED SET SCREW, ROD AND SCREW WERE REMOVED; AND AFTER INSERTING A SCREW OF BIGGER SIZE, THE ROD AND SET SCREW WERE RE-INSERTED. THE OPERATION WAS THEN FINISHED AFTER FINAL TIGHTENING. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. BONE QUALITY WAS DETERMINED TO BE BAD BY THE SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 9859612 ↗
• MalfunctionFeb 12, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS. SHE UNDERWENT COMBINED ANTERIOR-POSTERIOR FIXATION AT L3-L5, OBLIQUE LUMBAR INTERBODY FUSION AT L3-L4 AND L4-L5, RIGHT/LEFT PERCUTANEOUS PEDICLE SCREW FIXATION AT L3-L5 IN DECUBITUS POSITION AND L3-L4 COMPRESSION. NAVIGATION AND FLUOROSCOPY WAS USED IN THIS PROCEDURE. COMPRESSION PROCEDURE WAS BEING PERFORMED FROM THE LEFT SIDE TO THE RIGHT SIDE. DURING THE COMPRESSION PROCEDURE, THE INTERVERTEBRAL DISC SPACE WAS FOUND A LITTLE NARROW; THEREFORE, IT WAS LIFTED UP A LITTLE WITH THE TRIAL. AFTER THAT, THE SCREW WAS INSERTED. WHEN COMPRESSION WAS APPLIED TO THE ALLEGED INTERVERTEBRAL DISC SPACE, TIP OF THE SCREW AT L3 ON THE RIGHT MOVED TO THE CRANIAL SIDE INSIDE THE VERTEBRAL BODY AROUND THE PEDICLE AS A RESULT OF COMPRESSION ON THE RIGHT SIDE. IN THE VIEW OF SALES REP, THE COMPRESSION HAD BEEN HEAVILY LOADED. THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT. THERE IS NO PLAN TO EXPLANT THE DEVIATED SCREW. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9701529 ↗
• InjuryJan 20, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCREW INSERTION AND PLACEMENT AT L2-3 WITH PPS, SCREW INSERTION AT S1 AND S2AI BY MINI-OPEN DUE TO PYOGENIC SPONDYLITIS AT L4-5. POST-OP, IT WAS FOUND THROUGH CT IMAGE THAT THE SCREWS ON BOTH SIDES OF S1 HAD DEVIATED INTO THE SPINAL CANAL BY MISTAKE. HENCE ON THE SAME DAY A RE-OPERATION WAS PERFORMED EMERGENTLY, IN WHICH SCREWS AT S1 WERE REMOVED. AFTER THAT, CROSSLINK PLACEMENT WAS PERFORMED ON THE CRANIAL SIDE THAN THE SCREW INSERTING POSITION OF S2AI, AND THE SET SCREWS OF S2AI AND S1 WERE REINSERTED AND TIGHTENING WAS PERFORMED AGAIN. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. PATIENT COMPLICATIONS IS UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9605123 ↗
• InjuryJan 20, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCREW INSERTION AND PLACEMENT AT L2-3 WITH PPS, SCREW INSERTION AT S1 AND S2AI BY MINI-OPEN DUE TO PYOGENIC SPONDYLITIS AT L4-5. POST-OP, IT WAS FOUND THROUGH CT IMAGE THAT THE SCREWS ON BOTH SIDES OF S1 HAD DEVIATED INTO THE SPINAL CANAL BY MISTAKE. HENCE ON THE SAME DAY A RE-OPERATION WAS PERFORMED EMERGENTLY, IN WHICH SCREWS AT S1 WERE REMOVED. AFTER THAT, CROSSLINK PLACEMENT WAS PERFORMED ON THE CRANIAL SIDE THAN THE SCREW INSERTING POSITION OF S2AI, AND THE SET SCREWS OF S2AI AND S1 WERE REINSERTED AND TIGHTENING WAS PERFORMED AGAIN. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. PATIENT COMPLICATIONS IS UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9605122 ↗