CD HORIZON® SOLERA® Spinal System 6530530Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169750258), received between Apr 4, 2019 and Dec 10, 2025 — classified as 3 injuries, 5 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Device Handling Problem; Device Handling Problem

  INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT LEVELS IMPLANTED WAS L4/L5/S1. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. REP CONFIRMED THAT THE TIGHTENING NUT WAS NOT TORQUED TO FAILURE AS PER CORRECT PROCEDURE. PRE OP DIAGNOSIS OF THE EVENT WAS PAIN DUE TO MICROMOVEMENTS AS THE SYSTEM WAS NOT FIXED. CLAMPING NUT NOT TIGHTENED. THE PRODUCT EXPLANTED ON (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 23775009 ↗
• MalfunctionMar 21, 2023Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED SETSCREW. THE TYPE OF PROCEDURE PERFORMED WAS FIXATION. IT WAS REPORTED THAT, PATIENT WAS TREATED WITH VOYAGER 5.5 SETSCREW. DURING THE ONE-MONTH POST-OP FOLLOW UP, THE X-RAY IMAGES SHOW A SET SCREW MOBILIZED. THE LOT NUMBER OF MOBILIZED SETSCREW WAS UNKNOWN, THERE WAS NO PLAN OF REVISION SURGERY AS THE PATIENT DOES NOT HAVE ANY SYMPTOMS AS A RESULT. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580344 ↗
• MalfunctionJul 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. IT WAS REPORTED THAT, THE S2 SET SCREW HAD COME OFF FOR THE PATIENT WHO HAS BEEN FIXATED WITH V5 ON TH9-S2, SO REOPERATION FOR THE REATTACHMENT OF THE SET SCREW WAS PERFORMED. LOOSENING WAS ALSO OBSERVED IN THE S1 AND L5 LEFT SET SCREWS, SO THEY WERE REPLACED WITH NEW SET SCREWS AFTER REMOVAL WITH THE SHAFT T27 DRIVER. DURING INTRA-OPERATIVELY, T27 SHAFT BROKE WHEN REMOVING THE SET SCREW ON THE LEFT SIDE OF L5. THE LEVELS IMPLANTED WERE L5 LEFT, S1, S2. THE DATE OF IMPLANT FOR S1 SCREW WAS UNKNOWN. THE LOOSENING OF L5 LEFT AND S1 SCREWS WERE OBSERVED DURING REVISION SURGERY INTRA-OPERATIVELY. THE REPORTED SETSCREW WAS EXPLANTED AND WAS DISCARDED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130315 ↗
• MalfunctionJul 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. IT WAS REPORTED THAT, THE S2 SET SCREW HAD COME OFF FOR THE PATIENT WHO HAS BEEN FIXATED WITH V5 ON TH9-S2, SO REOPERATION FOR THE REATTACHMENT OF THE SET SCREW WAS PERFORMED. LOOSENING WAS ALSO OBSERVED IN THE S1 AND L5 LEFT SET SCREWS, SO THEY WERE REPLACED WITH NEW SET SCREWS AFTER REMOVAL WITH THE SHAFT T27 DRIVER. DURING INTRA-OPERATIVELY, T27 SHAFT BROKE WHEN REMOVING THE SET SCREW ON THE LEFT SIDE OF L5. THE LEVELS IMPLANTED WERE L5 LEFT, S1, S2. THE DATE OF IMPLANT FOR L5 LEFT SCREW WAS UNKNOWN. THE LOOSENING OF L5 LEFT AND S1 SCREWS WERE OBSERVED DURING REVISION SURGERY INTRA-OPERATIVELY. THE REPORTED SETSCREW WAS EXPLANTED AND WAS DISCARDED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130099 ↗
• InjuryJul 29, 2022Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE S2 SET SCREW HAD COME OFF FOR THE PATIENT WHO HAS BEEN FIXATED WITH V5 ON TH9-S2, SO REOPERATION FOR THE REATTACHMENT OF THE SET SCREW WAS PERFORMED. LOOSENING WAS ALSO OBSERVED IN THE S1 AND L5 LEFT SET SCREWS, SO THEY WERE REPLACED WITH NEW SET SCREWS AFTER REMOVAL WITH THE SHAFT T27 DRIVER. DURING INTRA-OPERATIVELY, T27 SHAFT BROKE WHEN REMOVING THE SET SCREW ON THE LEFT SIDE OF L5. THE LEVELS IMPLANTED WERE L5 LEFT, S1, S2. THE LOOSENING OF L5 LEFT AND S1 SCREWS WERE OBSERVED DURING REVISION SURGERY INTRA-OPERATIVELY. THE REPORTED SET SCREW WAS EXPLANTED AND WAS DISCARDED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129685 ↗
• MalfunctionFeb 18, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A LUMBAR INTERBODY FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH L4 SPONDYLOLISTHESIS. IT WAS REPORTED THAT L4 SET SCREWS IDLED AND THE FINAL TIGHTENING COULD NOT BE PERFORMED. AFTER THE EVENT OCCURRED, THE ROD REDUCER WAS USED AND THE INSTALLATION WAS SUCCEEDED. THE STEPS OF THE SUCCESS WERE THAT THE EXTENDER WAS HELD WITH THE ROD BEING DROPPED INTO, AND THEN THE SET SCREWS WERE INSERTED. THE REPORTED SCREWS WERE INSERTED INTO THE PATIENT'S BODY THROUGH THE EXTENDER ONCE. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556234 ↗
• InjuryJul 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF), PERCUTANEOUS PEDICLE SCREW (PPS) SURGERY AT L3/4/5 DUE TO THE SET SCREW WAS LOOSENED. IT WAS MENTIONED THAT INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. HENCE ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED IN WHICH THE LOOSENED SET SCREW WAS REPLACED. THERE WERE NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10300164 ↗
• MalfunctionApr 4, 2019Material Deformation; Material Deformation

  PRE OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE USED: L3/4/5 OBLIQUE LUMBAR INTERBODY FUSION (OLIF) , L5/S POSTERIOR LUMBAR INTERBODY FUSION(PLIF) L3/S; PEDICLE SCREW FIXATION(PPS) LEVELS IMPLANTED: L3/S IT WAS REPORTED THAT INTRA-OP, AFTER PLACING THE SET SCREW, COMPRESSION WAS PERFORMED WITH FULCRUM, AND ATTEMPTED TO BREAK OFF THE SET SCREW WHICH WAS PLACED ON LEFT L5, BUT IT COULD NOT BE BROKEN OFF. WHEN ATTEMPTED TO REMOVE THE DRIVER OF THE SET SCREW AND ATTACH IT AGAIN, THE SET SCREW COULD NOT BE GRIPPED. THE SET SCREW WAS REMOVED BY THE DRIVER, AND NEW SET SCREW WAS PLACED BUT AGAIN IT COULD NOT BE BROKEN OFF, THE SCREW WAS REPLACED AND BROKEN OFF, AND THE OPERATION WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8481592 ↗