CD HORIZON® Spinal System 9010000849 (UDI 00643169537736)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00643169537736), received between Feb 11, 2019 and Jun 12, 2026 — classified as 2 deaths, 40 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (19 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break; Misassembled

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING ROD INSERTERS USED IN POSTERIOR SIDE OF AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT THE L4-S1 SPINAL LEVELS. IT WAS REPORTED THAT STERILE PROCESSING TAKE APART THE INSERTER BUT WHEN TRYING TO REASSEMBLE IT BACK DURING A PROCEDURE, IT CANNOT BE PUT BACK TOGETHER. 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 25481659 ↗
• MalfunctionMay 26, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE MIS THORACOLUMBAR FUSION. IT WAS REPORTED THAT UNABLE TO ADJUST TENSION OF ROD INSERTER. WILL NOT HOLD ROD PROPERLY. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274518 ↗
• MalfunctionMar 24, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND THE ENAMEL WITHIN THE TRAY WAS FLAKING AND CAUSING CONTAMINATION CONCERNS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. EVENTS OCCURRED ON THE BACK TABLE. INSERTER WOULD NO LONGER CLAMP DOWN ON A ROD TO SECURE THE ROD FOR INSERTION AND THE PROBE'S TIP WAS DAMAGED / CHIPPED. NOTHING PHYSICALLY BROKE OFF. THREADS WERE DAMAGE AND WOULDN'T ATTACH TO A TRIAL AND TIP OF THE DRIVER SNAPPED OFF WHILE ATTEMPTING TO ATTACH A SCREW TO THE DRIVER AND ALL INSTRUMENTS WERE PREVIOUSLY USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673270 ↗
• MalfunctionMar 11, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR ROD DEPLOYMENT. IT WAS REPORTED THAT INSTRUMENT WON'T HOLD THE ROD SECURELY EVEN WHEN THE ADJUSTMENT IS TIGHTENED DOWN ALL THE WAY. THERE WAS NO PATIENT I NVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566770 ↗
• MalfunctionMar 5, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING USE. IT WAS REPORTED THAT FOR THE INSERTER THE RETAINING TRIGGER ON THE BACK OF THE INSTRUMENT DOES NOT ENGAGE THE CLAMP THAT PINCHES AND SECURES THE ROD TO THE INSTRUMENT. THE EVENT HAPPENED ON THE BACK TABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519081 ↗
• MalfunctionFeb 6, 2026Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A INSERTER USED FOR SPINAL THE RAPY. IT WAS REPORTED THAT THE INSTRUMENT DID NOT CLASP ONTO THE ROD ANYMORE, AND SOMETHING BROKE INSIDE THE LATCHING MECHANISM. 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 24275582 ↗
• MalfunctionJan 19, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR POSTERIOR FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER PERCUTANEOUS ROD WAS NOT FIXED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108120 ↗
• MalfunctionJan 12, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED IN A SPINAL THER APY. IT WAS REPORTED THAT THE INSERTER DID NOT CLAMP DOWN ONTO THE ROD OR TIGHTEN AT ALL, AND THE INSTRUMENT BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033180 ↗
• MalfunctionJan 6, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT INSERTER WAS BROKEN. 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 23972070 ↗
• MalfunctionDec 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED IN AN UNKNOWN SP INAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765938 ↗
• MalfunctionDec 1, 2025Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR SCOLIOSIS. REPORTED INSTER HAS BEEN USED FOR ANTERIOR LUMBAR INTERBODY FUSION, DIRECT LATERAL INTERBODY FUSION, OSTEOTOMIES, POST FIXATION FROM T8 TO S1. IT WAS REPORTED THAT THE INTERNAL MECHANISM OF THE PERCUTANEOUS INSERTER WAS STRAINED AND BROKE WHEN THE INSERTER WAS TIGHTENED AND ATTACHED TO THE ROD. THE PRODUCT WAS NOT UTILIZED ACCORDING TO THE DIRECTIONS GIVEN IN THE INSTRUCTIONS FOR USE/LABELING. INSERTER BROKE BECAUSE OF USER ERROR. NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677946 ↗
• MalfunctionNov 5, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INSTRUMENT DID NOT HOLD THE ROD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476310 ↗
• MalfunctionSep 9, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION (TLIF) THERAPY. IT WAS REPORTED THAT THE INSERTER DID NOT TIGHTEN PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001191 ↗
• MalfunctionAug 27, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED FOR MINIMALLY INVASIVE TRAN FORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT DRIVER HEAD SNAPPED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2025 AUG 12, EMAIL(REP) : THE ROD INSERTED DOES NOT LOCK DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904501 ↗
• MalfunctionJul 28, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR PERCUTANEOUS POSTERIOR SPINAL FUSIONS. IT WAS REPORTED THAT THE ROD HOLDER WOULD NOT HOLD THE ROD CORRECTLY. AS THE INTERNAL MECHANISM IS NO LONGER WORKING PROPERLY. 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 22628565 ↗
• MalfunctionJun 18, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE CHECKING IF THE INSTRUMENT WAS WORKING IN STERILE PROCESSING DEPARTMENT (SPD), THE ROD GRIPPER DID NOT CLOSE DOWN ON THE ROD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22269101 ↗
• MalfunctionJun 17, 2025Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING AN INSPECTION, THE DEVICE WOULD NOT CLAMP DOWN FULLY ONTO THE ROD AND WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED. AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IT IS UNSURE IF BROKEN OR SOMETHING JUST LOOSE BUT THE DISTAL TIP OF THE INSERTER THAT ATTACHES TO THE ROD WILL NOT FULLY ENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235319 ↗
• MalfunctionJun 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING AN INSERTER USED FOR MIS TLIF (L2-S1) IT WAS REPORTED THAT PERC ROD INSERTER WOULDN¿T HOLD A ROD. 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 22177257 ↗
• MalfunctionJun 5, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INTERNAL MECHANISM OF THE INSERTER, WHICH TIGHTENS THE INSTRUMENT TO HOLD THE ROD, WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155804 ↗
• MalfunctionMay 29, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS SPINAL FUSION FOR TRAUMATIC THORACIC BURST FRACTURE AT T8-T12 LEVELS. IT WAS REPORTED THAT DURING SURGERY, WHEN ATTEMPTED TO LOAD PERCUTANEOUS ROD ONTO THE INSERTER, THE INSERTER WOULD NOT FIRMLY HOLD THE ROD. WHEN ATTEMPTED TO TIGHTEN THE ROD INSERTER USING A T25 DRIVER, THE ROD WOULD STILL NOT HOLD FIRM. USING A SEPARATE INSERTER, THE SURGERY CONTINUED WITHOUT ANY FURTHER ISSUE. LATER IT WAS CONFIRMED THAT THE INSERTER WAS BROKEN AND INCAPABLE OF HOLDING PERCUTANEOUS ROD RIGIDLY DESPITE TIGHTENING. THE DAMAGE TO PRODUCT WAS IDENTIFIED BY SCRUB TECH AND HIMSELF DURING INITIAL SETUP. IT WAS REMOVED FROM THE FIELD AND A DUPLICATE INSTRUMENT WAS USED SUCCESSFULLY. DAMAGED PRODUCT CAUSED NO DELAY TO PROCEDURE TIME. IT DID NOT COME IN CONTACT W/ THE PATIENT. 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 22103733 ↗
• MalfunctionApr 17, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER FOR THE PERCUTANEOUS ROD WAS NOT FUNCTIONING AS THE ROD HOLD WAS NOT WORKING. THERE WAS NO BREAKAGE OF THE INSTRUMENT OR IMPLANT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854350 ↗
• MalfunctionMar 27, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN PERCUTANEOUS POSTERIOR SCREW FIXATION THERAPY FOR BACK PAIN, SCIATICA. LEVELS IMPLANTED WERE L5-S1. IT WAS REPORTED THAT UPON IMPLANTING THE PERCUTANEOUS ROD ON THE PATIENT¿S LEFT SIDE, THERE WAS A SNAPPING NOISE. UPON HEARING THE NOISE, THE SURGEON PULLED THE INSERTER OUT OF THE WOUND AND REALIZED THE ROD HAD RELEASED FROM THE INSERTER. ROD WAS THEN FISHED OUT WITH A KOCHER. ATTEMPTED TO RE-ENGAGE ROD WITH INSERTER BUT THE INSERTER WAS NOT WORKING PROPERLY AND WOULD NOT ENGAGE ROD ANY LONGER. 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 21705037 ↗
• MalfunctionFeb 24, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE ROD HOLDER DOESN¿T LOOSEN UP ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442949 ↗
• MalfunctionJan 28, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS R REPORTED THAT THE INSERTER WOULD NOT EDGE THE ROD AND WOULD NOT HOLD THE ROD. INSERTER WON¿T HOLD THE SET SCREWS AND WAS USED NUMEROUS TIMES. 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 21251852 ↗
• MalfunctionJan 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR LATERAL MIS FUSION. IT WAS REPORTED THAT THE ROD CLAMPING MECHANISM MALFUNCTIONED. 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 21122127 ↗