CD HORIZON® Spinal System 5484902Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169177024), received between May 19, 2017 and May 3, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 3, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE INSTRUMENTS WERE BENT AND THEREFORE THEY COULD NOT BE USED PROPERLY. THE EXTENDERS DIDN'T HOLD THE SCREWS PROPERLY AND THE REDUCERS DIDN'T PUSH THE ROD DOWN PROPERLY. THAT'S WHY SOME SCREWS CAME LOOSE FROM THE EXTENDERS WHEN THE ROD WAS REDUCED. THE SCREWS HAD TO BE RESET AND CEMENTED AGAIN. THE CONSTRUCT DID NOT HOLD, SO THE PATIENT HAD TO BE REVISED NEXT WEEK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236671 ↗
• InjuryMay 3, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE INSTRUMENTS WERE BENT AND THEREFORE THEY COULD NOT BE USED PROPERLY. THE EXTENDERS DIDN'T HOLD THE SCREWS PROPERLY AND THE REDUCERS DIDN'T PUSH THE ROD DOWN PROPERLY. THAT'S WHY SOME SCREWS CAME LOOSE FROM THE EXTENDERS WHEN THE ROD WAS REDUCED. THE SCREWS HAD TO BE RESET AND CEMENTED AGAIN. THE CONSTRUCT DID NOT HOLD, SO THE PATIENT HAD TO BE REVISED NEXT WEEK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236657 ↗
• InjuryMay 3, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE INSTRUMENTS WERE BENT AND THEREFORE THEY COULD NOT BE USED PROPERLY. THE EXTENDERS DIDN'T HOLD THE SCREWS PROPERLY AND THE REDUCERS DIDN'T PUSH THE ROD DOWN PROPERLY. THAT'S WHY SOME SCREWS CAME LOOSE FROM THE EXTENDERS WHEN THE ROD WAS REDUCED. THE SCREWS HAD TO BE RESET AND CEMENTED AGAIN. THE CONSTRUCT DID NOT HOLD, SO THE PATIENT HAD TO BE REVISED NEXT WEEK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236650 ↗
• InjuryMay 3, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE INSTRUMENTS WERE BENT AND THEREFORE THEY COULD NOT BE USED PROPERLY. THE EXTENDERS DIDN'T HOLD THE SCREWS PROPERLY AND THE REDUCERS DIDN'T PUSH THE ROD DOWN PROPERLY. THAT'S WHY SOME SCREWS CAME LOOSE FROM THE EXTENDERS WHEN THE ROD WAS REDUCED. THE SCREWS HAD TO BE RESET AND CEMENTED AGAIN. THE CONSTRUCT DID NOT HOLD, SO THE PATIENT HAD TO BE REVISED NEXT WEEK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236639 ↗
• InjuryMay 3, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE INSTRUMENTS WERE BENT AND THEREFORE THEY COULD NOT BE USED PROPERLY. THE EXTENDERS DIDN'T HOLD THE SCREWS PROPERLY AND THE REDUCERS DIDN'T PUSH THE ROD DOWN PROPERLY. THAT'S WHY SOME SCREWS CAME LOOSE FROM THE EXTENDERS WHEN THE ROD WAS REDUCED. THE SCREWS HAD TO BE RESET AND CEMENTED AGAIN. THE CONSTRUCT DID NOT HOLD, SO THE PATIENT HAD TO BE REVISED NEXT WEEK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236631 ↗
• MalfunctionMar 31, 2021Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING REDUCER USED FOR PSF PROCEDURE. IT WAS REPORTED THAT THE REDUCING TOWER WAS LOOSE AND AFTER INSPECTING IT POST OP, THE SHIMS IN THE TOP OF THE REDUCER WERE OUT OF ALIGN AND THE INSTRUMENT BROKE. PRODUCT CAME IN PATIENT CONTACT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593910 ↗
• MalfunctionMar 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF COMPRESSION FRACTURE AT L3. IT WAS REPORTED THAT WHEN THE RATCHET HANDLE AND REDUCTION NUT DRIVER WERE COMBINED AND THE REDUCTION NUT WAS TURNED, THE O RING AND PACKING INSIDE THE REDUCTION NUT WERE BROKEN. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO FRAGMENTS OF INSTRUMENTS LEFT IN PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. WHEN TIGHTENING THE NUT OF THE REPORTED PRODUCT AND PUSHING DOWN THE ROD, THE RING OF THE EXTENDER CONNECTION PART WAS BROKEN BEFORE THE RD SIGNAGE APPEARED. THE PHYSICIAN'S VIEW THAT THERE WAS NOT MUCH GAP BETWEEN THE ROD AND SCREW HEAD, AND IT DID NOT SEEM THAT THE LOAD WAS APPLIED. A ROD WAS PLACED ON THE SEQUENTIAL REDUCER ON THE CRANIAL AND CAUDAL SIDE OF THE REPORTED LOCATION. AFTER THAT, WHEN A DRIVER WAS INSERTED OVER THE PRODUCT, TEMPORARILY FIXED, AND THEN THE DRIVER WAS REMOVED, THE REPORTED PRODUCT WAS TAKEN OUT FROM THE EXTENDER TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472077 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L2 BURST FRACTURE, AND UNDERWENT SPINAL FUSION AT TWO LEVELS ABOVE AND TWO LEVELS BELOW L2. INTRA-OP, WHILE TURNING THE SEQUENTIAL REDUCER ON THE LEFT SIDE OF L3 TO PUSH THE ROD DOWN, THE EXTENDER DISCONNECTED FROM THE REPORTED SEQUENTIAL REDUCER AND THE ROD COULD NOT BE PLACED. THE SAME HAD OCCURRED PREVIOUSLY WITH ANOTHER SEQUENTIAL REDUCER BUT SAME EXTENDER. HENCE, IT WAS THEN THOUGHT THAT THE SEQUENTIAL REDUCER WAS NOT RESPONSIBLE FOR THE REPORTED EVENT. THE PEDICLE SCREW WAS LOOSENED SLIGHTLY AND THE BENDING OF THE ROD WAS CHECKED, BUT NO CHANGE ABOUT THE SITUATION OCCURRED. FINALLY, THE EXTENDER AT LEFT SIDE OF L3 WAS REMOVED, THE ROD WAS PLACED WITH AN OFFSET COUNTER TORQUE AND THE SET SCREW WAS INSERTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT, BUT NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287281 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L2 BURST FRACTURE, AND UNDERWENT SPINAL FUSION AT TWO LEVELS ABOVE AND TWO LEVELS BELOW L2. INTRA-OP, WHILE TURNING THE SEQUENTIAL REDUCER ON THE LEFT SIDE OF L3 TO PUSH THE ROD DOWN, THE EXTENDER DISCONNECTED FROM THE REPORTED SEQUENTIAL REDUCER AND THE ROD COULD NOT BE PLACED. WHILE CHECKING, IT WAS FOUND THAT AT THE STAGE OF CONNECTING THE SEQUENTIAL REDUCER AND EXTENDER, THE ATTACH BUTTON OF THE SEQUENTIAL REDUCER WAS NOT OPENED COMPLETELY. IT WAS IN A STATE THAT THE SEQUENTIAL REDUCER AND EXTENDER WERE NOT LOCKED SECURELY. ALTHOUGH THE SEQUENTIAL REDUCER WAS REPLACED WITH ANOTHER ONE, THE EXTENDER AND THE NEW SEQUENTIAL REDUCER DISCONNECTED AGAIN. IT WAS THEN THOUGHT THAT THE SEQUENTIAL REDUCER WAS NOT RESPONSIBLE FOR THE REPORTED EVENT. THE PEDICLE SCREW WAS LOOSENED SLIGHTLY AND THE BENDING OF THE ROD WAS CHECKED, BUT NO CHANGE ABOUT THE SITUATION OCCURRED. FINALLY, THE EXTENDER AT LEFT SIDE OF L3 WAS REMOVED, THE ROD WAS PLACED WITH AN OFFSET COUNTER TORQUE AND THE SET SCREW WAS INSERTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT, BUT NO PATIENT COMPLICATIONS WERE REPORTE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287272 ↗
• MalfunctionMar 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PEDICLE SCREW FIXATION (PPS) SURGERY AT T12/L1/L3 DUE TO L2 BURST FRACTURE. INTRA-OP, ON THE RIGHT SIDE OF T12, THE REDUCER WAS USED TO DROP THE ROD DOWN. WHEN THE REDUCER HAD BEEN DROPPED DOWN WITH THE REDUCTION NUT DRIVER AND THE EGG HANDLE, THE NUT PART OF THE REDUCER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS SAID THAT SINCE IT BECAME UNABLE TO USE THE REDUCER, THE EXTENDER WAS REMOVED AND THE ROD WAS PRESSED DOWN USING THE COUNTER TORQUE, AND FINAL TIGHTENING COULD BE PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9858661 ↗
• MalfunctionOct 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN EXTENSION OF FIXATION RANGE FROM L3-L4 TO L2-L5. THE SET CAPS AND ROD WERE REMOVED. SCREWS AT L2 AND L5 WERE PLACED, AND REDUCERS/EXTENDERS WERE USED TO AID WHEN SEATING THE ROD. INTRA-OP, IT WAS OBSERVED THAT ONE OF THE REDUCERS COULD NOT STAY RETAINED ON THE TULIP OF THE SCREW. THE PHYSICIAN TRIED A COUPLE OF TIMES BUT THE REDUCER WOULDN'T STAY. THEN, THIS REDUCER WAS REMOVED IMMEDIATELY FROM USE AND THE STERILE FIELD, AND ANOTHER ONE WAS USED FROM THE TRAY. THERE WAS NO FURTHER ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9155469 ↗
• MalfunctionJan 18, 2018Break; Break

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE LUMBAR SCOLIOSIS AND UNDERWENT POSTEROLATERAL FUSION ON TH10/L4. INTRA-OP, DURING PLACING THE ROD, THE HEX PART ON THE DORSAL SIDE WAS BROKEN. SURGERY WAS PERFORMED AT THE CAUDAL THREE VERTEBRAL BODIES WITH MINIMALLY INVASIVE SURGERY PERFORMED ON THE CRANIAL SIDE. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO FRAGMENTS REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7204704 ↗
• MalfunctionMay 19, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT, PRE-OPERATIVELY DIAGNOSED WITH PARKINSON'S DISEASE, UNDERWENT POSTERIOR FUSION SURGERY. INTRA-OPERATIVELY AFTER THE SPINAL CORRECTION USING TRAUMA DEVICE, THE DOCTOR MIGHT HAVE TIGHTENED A REDUCER TOO MUCH USING A REDUCTION NUT DRIVER. DURING ROD REDUCTION, THE RING OF THE REDUCER BROKE. AS RESULT OF WHICH A PART CAME OFF FROM THE REDUCER. THE BROKEN ONE WAS REPLACED WITH ANOTHER ONE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577675 ↗