CD HORIZON® SOLERA® Spinal System 6540530Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169750241), received between Apr 17, 2019 and Sep 24, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Distributor) regarding a Patient h aving Spinal therapy. It was reported that during lumbar vertebral implant procedure involving placement of a Solera Voyager screw, rod positioning, and locking cap tightening, the ridges detached from the locking cap. The physician replaced the affected locking cap with a different locking cap. No patient complications, injury, hospitalization, or medical or surgical intervention to prevent permanent impairment were reported as a result of this event. Additional information was received that reporting that after the pedicle screw and rod were placed, the physician attempted to tighten the locking screw (6540530) clockwise but noticed it was not tightening properly. Upon removing and inspecting the device, the physician observed that one of the ridges had detached from the locking mechanism and the other ones were severely damaged; consequently, a different device was used, which functioned properly. There was no issue with the rod, it was only with the locking screw.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880920 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT AN ADDITIONAL SPINAL SURGERY WAS PERFORMED AT L1, T12 ON (B)(6) 2025 DUE TO SURGICAL DEBRIDEMENT OF WOUND.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22325592 ↗
• MalfunctionApr 3, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-S1 POSTERIOR SPINAL FUSION WITH AN L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY. IT WAS REPORTED THAT ON THE FOLLOW-UP X-RAY,  IT WAS NOTICED ON THE LATERAL X-RAY THAT A SET SCREW IS UNATTACHED ABOVE THE L2 PEDICLE SCREWS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DISCONNECTED SET SCREW WAS NOTICED WHEN X-RAYS WERE TAKEN DURING A POSTOPERATIVE VISIT. THE PATIENT RECEIVED A RE-OPERATION FOR A SUSPECTED INFECTION. DURING THE PROCEDURE, THE LOOSE SET SCREW WAS REMOVED AND A NEW SET SCREW WAS USED TO FIXATE THE ROD. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO ASSOCIATE WITH THE INFECTION TO ANY OF THE HARDWARE, INCLUDING THE SET SCREW THAT DISENGAGED FROM THE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 21761861 ↗
• MalfunctionFeb 24, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE UPON FULLY SEATING ROD INTO POLYAXIAL SCREW, THE SET SCREW BEGAN TO STRIP AND WAS UNABLE TO ENGAGE THE POLYAXIAL HEAD. ADDITIONALLY, WHEN SURGEON PLACED BALL ENDED DRIVER INTO THE SHANK OF THE SCREW AND ATTEMPTED TO ADVANCE THE SCREW. THE SCREW WAS UNABLE TO BE ADVANCED THE BALL-ENDED DRIVER AS TIP SHEARED OFF, LEAVING THE TIP INSIDE THE SCREW SHANK AT THE S1 LOCATION ON THE PATIENT'S LEFT SIDE. DESPITE SEVERAL ATTEMPTS, THE TIP OF THE DRIVER COULD NOT BE RETRIEVED. THE PRODUCT WAS EXPLANTED AND NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ALLEGATION AGAINST SCREW. THERE IS NO REVISION SURGERY SCHEDULED OR PLANNED FOR REMOVAL OF BROKEN FRAGMENT. PROCEDURE INVOLVED IN THE EVENT WAS L3-5 LATERAL FUSION, L5-S1 TLIF, L3-S1 FIXATION WITH PERC SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21444118 ↗
• MalfunctionOct 21, 2024Break; Mechanical Problem; Material Deformation; Break; Mechanical Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490950 ↗
• MalfunctionOct 21, 2024Break; Mechanical Problem; Material Deformation; Break; Mechanical Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490911 ↗
• MalfunctionOct 4, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A SET SCREW HAVING SPINAL THER APY. IT WAS REPORTED THAT SET SCREW WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367124 ↗
• MalfunctionOct 4, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A SET SCREW HAVING SPINAL THER APY. IT WAS REPORTED THAT SET SCREW WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367055 ↗
• MalfunctionMay 7, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SET SCREW AND SCREW HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) USING VOYAGER WITH CAPPED ROD. IT WAS REPORTED THAT THE SET SCREW THAT WOULDN¿T ENGAGE WITH THE SCREW AND THE SET SCREW WOULD NOT BREAK OFF. THERE WAS ADDED 30 MINS TO THIS CASE. THE SCREW WAS REPLACED AND HAD TO BE HAND-TIGHTENED DOWN WITH THE CAP. 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 19257922 ↗
• InjuryJun 28, 2022Loosening 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 HAVING SPINAL THERAPY. IT WAS REPORTED THAT PATIENT REPORTED FEELING POP. UPON FURTHER EVALUATION, PHYSICIAN DISCOVERED BY X-RAY THAT A SET SCREW HAD COME LOOSE AND CAGE HAD BACKED OUT. THE DEVICES WERE EXPLANTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE: PROCEDURE INVOLVED - L4-S1 TLIF THERE WAS A DELAY IN THE PROCEDURE BY MORE THAN 60 MINS, AS REVISION SURGERY HAD TO BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14839670 ↗
• InjuryMar 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PRE OP DIAGNOSIS: LOOSE SET SCREWS PROCEDURE PERFORMED: REVISION SURGERY TO REPLACE LOOSE SET SCREWS POST-OP, SET SCREWS BACK OUT. INITIAL POST OP X-RAY LOOKED INTACT BUT FOLLOW UP X-RAY SET SCREW ON RIGHT L5 SCREW NOTED TO BE NOT SITTING IN SCREW HEAD. REVISION SURGERY UNDERTAKEN TO REPLACE SET SCREW. THE PATIENT SUFFERED PAIN AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 9892534 ↗
• InjuryMar 12, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L4-S1 DUE TO SPINAL CANAL STENOSIS. THE PLAN WAS FOR AN L5/S1 INSTRUMENTED FUSION. PATIENT HAD L5/S1 PEDICLE SCREWS INSERTED ON THE LEFT SIDE. THE RIGHT L5 PEDICLE WAS BROKEN DUE TO THE SCREW BEING RE-POSITIONED MULTIPLE TIMES. THE SURGEON DECIDED TO SKIP THE RIGHT L5 PEDICLE, AND EXTEND TO L4 ON THE RIGHT SIDE. SO THE PATIENT HAD SCREWS INSERTED INTO THE LEFT L5/S1 PEDICLES, AND THE RIGHT L4 AND S1 PEDICLES.. POST-OP, THE IMPLANTED SETSCREW WAS POPPED OFF FROM THE RIGHT L4 SCREW. THE PATIENT UNDERWENT THE REVISION SURGERY AS A RESULT OF THIS EVENT WHERE THE ALLEGED SETSCREW WAS REMOVED WITH THE ASSOCIATED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9822163 ↗
• InjuryApr 17, 2019Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION (PSF), LATERAL DUE TO KYPHOSIS, SPONDYLOSIS, RADICULOPATHY, STENOSIS. POST-OP, THE SET SCREW PULLED AWAY FROM ROD. NO MALFUNCTION WAS NOTED FOR THE ROD. THE CONSTRUCTS WERE EXPLANTED IN A REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521561 ↗