CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016545Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169501065), received between Apr 10, 2018 and Jan 17, 2025 — classified as 1 death, 2 injuries, 6 malfunctions.

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

• MalfunctionJan 17, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, DURING THE OBLIQUE LUMBAR INTERBODY FUSION AND LATERAL POSITION POSTERIOR PEDICLE SCREW, THE SCREW'S TRACK WAS NEAR THE DISC, SO IT WAS DECIDED TO RE-INSERT THE SCREW. WHEN THE SCREW WAS REMOVED, IT WAS DISCOVERED THAT THE THREAD WAS DAMAGED, SO IT WAS REPLACED WITH A NEW SCREW AND RE-INSERTED. THE LEVELS TREATED WERE L5. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176349 ↗
• MalfunctionNov 26, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN L4 BALLOON KYPHOPLASTY L3/4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L4 COMPRESSION FRACTURE L3/4/5 LSCS. IT WAS REPORTED THAT THE SET SCREW WAS STRIPPED. NO 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 20779005 ↗
• MalfunctionSep 23, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR CANAL STENOSIS ASSOCIATED WITH DEGENERATIVE LUMBAR SCOLIOSIS. IT WAS REPORTED THAT, THE HEAD MIGHT HAVE SPREAD OUT WITH CROSS THREADING BECAUSE THE BREAKING OFF OF A SETSCREW COULD NOT BE DONE WHEN THE FINAL WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED. THE LEVELS TREATED WERE L2/3/4/5. PROCEDURE/TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION (OLIF). THE SETSCREWS WERE IDENTIFIED WITH SLIGHT WEAR ON THE THREADS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278154 ↗
• MalfunctionMay 6, 2024Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY FOR L1 COMPRESSION FRACTURE. LEVELS IMPLANTED WAS TH11-L2. IT WAS REPORTED THAT THE PRODUCT WAS OPENED FOR USE, BUT THE EXTENDER'S ATTACHED PORTION CLAWS WERE ALREADY BENT. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS NOT USED AND THE PATIENT. THE ISSUE WAS NOTICED RIGHT AFTER THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246706 ↗
• InjuryNov 18, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING TREPHINES USED IN L5/S LCS L4-S POSTERIOR FIXATION, L5/S TLIF. LEVEL IMPLANTED: L5 LEFT IT WAS REPORTED THAT THE AREA AROUND THE SCREW WAS CHANGED TO THE SHAPE OF BONE RESECTION OSTECTOMY WITH AIRTOME AND FLEA. A PHENOMENON OCCURRED IN WHICH THE AREA AROUND THE BROKEN SCREW COULD NOT BE CUT DOWN COMPLETELY WHEN CUTTING WITH A TREPHINE. WHEN THE TIP OF THE TREPHINE WAS CHECKED, IT WAS CONFIRMED THAT THE BURR BECAME SMOOTH AND ROUNDED. THE EVENT WAS A REPEAT SURGERY FOR A SCREW FRACTURE. THE NAIL WAS REMOVED. THEREWAS A DELAY OF MORE THAN 60 MINS. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824224 ↗
• MalfunctionDec 13, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L3-L5 LUMBAR SPINAL CANAL STENOSIS; AND UNDERWENT MONO-PORTAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3-L5. TLIF WAS PERFORMED FROM L3-L4 AFTER DECOMPRESSION, AND THE SURGEON BEGAN TO PERFORM POSTERIOR FIXATION BY WILTZ APPROACH AFTER PERFORMING TLIF AT L4-L5. PEDICLE SCREW INSERTION WAS PERFORMED FROM L3 ON THE RIGHT SIDE, AND SCREW INSERTION AND FINAL TIGHTENING WERE COMPLETED AT L3-L5 ON THE RIGHT SIDE SUCCESSFULLY. PEDICLE SCREW INSERTION WAS STARTED FROM L3 ON THE LEFT SIDE, AND THE PILOT HOLES OF THE SCREWS UP TO L5 WERE PREPARED, AND SAGITTAL IMAGE WAS CONFIRMED. INSERTION WAS PERFORMED AGAIN AT L4 AND L5, AND PEDICLE SCREWS WERE INSERTED STARTING FROM L3. WHEN THE ROD WAS INSERTED, IT SEEMED THAT L4 SCREW WAS OBVIOUSLY OUTSIDE. SET SCREW WAS DROPPED IN THE SCREW AND WAS TIGHTENED; BUT IDLING OCCURRED. THE SET SCREW WAS THEN REPLACED WITH ANOTHER ONE; BUT STILL THE IDLING OCCURRED. ALL OF THE SET SCREWS AND THE ROD WERE REMOVED, AND THE SCREW AT L4 WAS REMOVED, AND ANOTHER SCREW WITH A DIAMETER OF 7.5 X 45MM WAS INSERTED AGAIN. AFTER THAT, THE ROD WAS INSERTED AGAIN, BUT IT STILL FELT STRANGE AND IDLING STILL OCCURRED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9469352 ↗
• DeathNov 1, 2019Break; Misassembly by Users; Break; Misassembly by Users

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PEDICLE SCREW FIXATION AT POSTERIOR SIDE OF T11-L5 DUE TO L2 VERTEBRAL BODY FRACTURE FROM A TUMBLE. INTRA-OP, THE SET SCREW ON THE LEFT SIDE OF L3 DID NOT ENGAGE WITH THE SCREW EVEN THOUGH IT WAS PUSHED. ALTHOUGH THE SET SCREW WAS CAUGHT ON, IT IDLED DURING TIGHTENING. THE TAB EXTENDER CAP HAD BEEN ATTACHED, BUT THE TAB OF THE SCREW BROKE; SO, THE SURGEON TRIED SKIN INCISION BUT THE SET SCREW DID NOT ENGAGE. THE SCREW WAS EXPLANTED AND A BIGGER SET SCREW WAS INSERTED AGAIN. THERE WAS A GAP NOTED BETWEEN THE ROD AND THE SCREW HEAD AS WELL. THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES DUE TO THIS EVENT. POST-OP, AFTER FINAL TIGHTENING AND WOUND CLOSURE WAS DONE WITHOUT PROBLEMS, WHEN PATIENT'S POSITION WAS CHANGED TO SUPINE POSITION, PATIENT'S CONDITION HAD A SUDDEN DETERIORATION AND THE NURSE REPORTED THE COLOR OF PATIENT'S FEET WAS NOT GOOD. THE CONDITION TURNED TO A CARDIAC ARREST STATE AND TREATMENT WAS PERFORMED AT THE OPERATION ROOM FOR MORE THAN AN HOUR. THE REASON SUSPECTED FOR HEALTH DETERIORATION WAS REPORTED THAT WHEN SETTING POSITION, ALTHOUGH VERTEBRAL BODY REDUCTION HAD BEEN PERFORMED, IT WAS FELT THAT THE ANT

  Patient problems: Thrombosis

  MAUDE report 9264987 ↗
• InjuryAug 27, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L4/L5 DUE TO LUMBAR SPINAL CANAL STENOSIS, RADICULOPATHY. POST-OP, THE SCREW WAS INSERTED INTO RIGHT OF L5 USING A NAVIGATION BUT THE INSERTED SCREW WAS TURNED OUT AND DEVIATED AFTER THE OPERATION. HENCE ON (B)(6) 2019, REVISION SURGERY WAS PERFORMED DUE TO THE SCREW DEVIATED. PATIENT SYMPTOMS OR COMPLICATIONS IS UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8934147 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS UNDERWENT PERCUTANEOUS PEDICLE SCREW FIXATION AT L3/5 AFTER OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, DURING TIGHTENING THE ROD, THE EXTENDER ROSE WHEN PLACING THE SET SCREW. THE REASON WAS THAT THE TAB ON ONE SIDE OF THE EXTENDER WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7410545 ↗