CD HORIZON® Spinal System NAV2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169347496), received between Dec 28, 2016 and May 6, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Break” (29 reports).

1 other recall cover devices cleared under the same FDA submission (K140454); they may or may not involve this specific model.

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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT TIP OF THE DRIVER WEAR OUT AND THE OTHER DRIVER HAD RUSTED THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO BREAKAGE OCCURRED TO BOTH OF THE DRIVERS AND THE DEVICES FOUND TO BE DEFECTIVE AFTER MANY USES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090461 ↗
• MalfunctionSep 2, 2025Break; Material Fragmentation; Break; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING DEVICE USED FOR SPINAL PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940802 ↗
• MalfunctionJul 1, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369472 ↗
• MalfunctionJun 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER BROKE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE THERAPY INVOLVED IS TLIF-TRANSFORAMINAL LUMBAR INTERBODY FUSION. AND THE TIP BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22271825 ↗
• MalfunctionFeb 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING OPEN LUMBAR FUSION THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT THE SCREW WAS NOT FULLY INSERTED AND HAD TO BE REMOVED AND REPLACED. ADDITIONALLY, THERE WERE REPEATED INSERTIONS OF PELVIC SCREWS DUE TO THE DRIVERS BREAKING. THE TIPS OF THE DRIVERS SHEARED OFF BEFORE THE SCREW WAS FULLY INSERTED. UNFORTUNATELY, THE TIP WAS NOW IN THE SCREW HEAD AND COULD NOT BE ADVANCED SO THE SCREW HAD TO REMOVED AND REPLACED WITH A NEW ONE. THE PLIERS DIDN'T WORK AND THE SPRING WAS JACKED UP. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419277 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED INSTRUMENT. PRE-OP DIAGNOSIS OF PATIENT WAS STENOSIS. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN WHILE INSERTING SCREW FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION. THE LEVELS PLANNED WERE L4-S1. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351986 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A SOLERA DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN DURING THE PREOP INSPECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. PRODUCT WASN'T RECEIVED AT THE FACILITY AS DEFECTIVE PRODUCT AND IT HAS BEEN USED IN OTHER SURGERIES. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293547 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR PSF. IT WAS RE PORTED THAT THE TIP BROKE OFF. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE EVENT HAPPENED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289865 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L3-PELVIS POSTERIOR SPINAL FUSION AND EXTENSION. IT WAS REPORTED THAT THE DRIVER BROKE TRYING TO REMOVE A SCREW. 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 21289588 ↗
• MalfunctionJan 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS INSPECTED DURING A QUARTERLY AUDIT OF SETS. IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193079 ↗
• MalfunctionJan 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF DRIVER WAS BROKEN. 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 21065296 ↗
• MalfunctionDec 12, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE BROKEN. 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 20912025 ↗
• MalfunctionDec 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN POSTERIOR LUMBAR INTERBODY FUSION SPINAL THERAPY FOR SPINAL STENOSIS. LEVELS IMPLANTED WERE L2-S1. IT WAS REPORTED THAT THE TIP OF THE DRIVER THAT BROKE OFF IS RETAINED IN THE HEAD OF THE SCREW. FRAGMENTS REMAINED IN THE PATIENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20851283 ↗
• MalfunctionAug 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW DRIVERS USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE DRIVERS BROKE. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940061 ↗
• MalfunctionAug 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW DRIVERS USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE DRIVERS BROKE. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939976 ↗
• MalfunctionApr 1, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR RADICULOPATHY L3/4. IT WAS REPORTED THAT THE TIP OF DRIVER WAS BROKEN WHILE INSERTING THE SCREW. NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660775 ↗
• MalfunctionMar 1, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE 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 16458331 ↗
• MalfunctionSep 14, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DRIVER IN A TLIF FOR A LUMBAR STENOSIS. IT WAS REPORTED THAT DRIVER TIP BROKE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE LEVELS IMPLANTED WERE L3-5. THE PRODUCT WAS USED IN OPERATION FIELD AND IN PATIENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465900 ↗
• MalfunctionJan 5, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PROCEDURE OF TLIF. IT WAS REPORTED THAT THE DRIVER¿S WERE BROKEN. IT WAS MENTIONED THAT THERE WERE NO FRAGMENTS OF BROKEN DRIVER¿S LEFT INSIDE THE PATIENT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. THE PRE-OPERATIVE DIAGNOSIS OF THE PATIENT WAS MENTIONED AS BACK-PAIN. THERE WERE NO SYMPTOMS TO PATIENT WERE REPORTED AS RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020: IT WAS REPORTED THAT THERE WAS NO DELAY REPORTED AS A RESULT OF THIS EVENT. IT WAS MENTIONED THAT THE PRODUCTS INVOLVED IN THIS EVENT CAME IN CONTACT WITH PATIENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115955 ↗
• MalfunctionJan 5, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PROCEDURE OF TLIF. IT WAS REPORTED THAT THE DRIVER¿S WERE BROKEN. IT WAS MENTIONED THAT THERE WERE NO FRAGMENTS OF BROKEN DRIVER¿S LEFT INSIDE THE PATIENT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. THE PRE-OPERATIVE DIAGNOSIS OF THE PATIENT WAS MENTIONED AS BACK-PAIN. THERE WERE NO SYMPTOMS TO PATIENT WERE REPORTED AS RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020: IT WAS REPORTED THAT THERE WAS NO DELAY REPORTED AS A RESULT OF THIS EVENT. IT WAS MENTIONED THAT THE PRODUCTS INVOLVED IN THIS EVENT CAME IN CONTACT WITH PATIENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115938 ↗
• MalfunctionJan 4, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT DRIVER WAS BROKEN. IT WAS MENTIONED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE TYPE OF PROCEDURE WAS MENTIONED AS REVISION. THERE WAS NO MALFUNCTION OF MEDTRONIC PRODUCTS THAT CAUSED TO PERFORM REVISION SURGERY. THERE WAS NO DELAY REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106673 ↗
• MalfunctionDec 29, 2020Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH STENOSIS FOR SPINAL THERAPY. PROCEDURE USED WAS LUMBAR FUSION. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT DRIVER TIP BROKE OFF IN SCREW WHEN TRYING TO ADVANCE IN THE HARD BONE. NO FRAGMENTS LEFT IN PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED. UPDATE ; WHILE ADVANCING A SCREW USING NAVIGATION, THE TIP OF THE DRIVER BROKE IN THE SCREW HEAD. THE PIECE WAS OBTAINED AND TAKEN OUT OF THE PATIENT. THE PATIENT HAD STENOSIS/HARD BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085993 ↗
• MalfunctionDec 16, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH A PRE-OP DIAGNOSIS OF THORACIC MYELOPATHY, CAUDA EQUINA SYNDROME, THORACIC STENOSIS AND ADJACENT LEVEL DISEASE. PATIENT HAD MEDICAL HISTORY OF HTN, MIGRAINES, DEPRESSION, ANEMIA. IT WAS REPORTED THAT DURING PSF PROCEDURE THE TIP OF DRIVER BROKE WHILE PUTTING SCREW IN. NO FRAGMENT OF THE DEVICE REMAINING IN THE PATIENT. LEVELS IMPLANTED T4-SAI. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO SURGICAL DELAY DUE TO REPORTED PRODUCT MALFUNCTION. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019641 ↗
• MalfunctionAug 20, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM AND INSTRUMENTS BEING USED INTRA-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING INSERTION OF S2AI SCREW, THE SURGEON BROKE 4 DIFFERENT SCREW DRIVERS. ALL DRIVERS SHOW OBVIOUS DAMAGE OR FRACTURE AT THE TIP OF THE INSTRUMENT. THERE WAS NOTICEABLE DENSITY ON THE IMAGING IN AREA OF S2AI SCREW PLACEMENT. THE SCREW DIAMETER WAS UNDER TAPPED BY 1MM BEFORE INSERTION. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT WAS REMAINING IN THE PATIENT. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CASE WAS COMPLETED WITH THE TWO ADDITIONAL SCREWDRIVERS THEY HAD AND THEY PLACED TRADITIONAL PELVIC SCREWS TO FINISH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10431506 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY DUE TO SOME UNSPECIFIED REASONS. INTRA-OP, TIP OF THE DRIVER BROKE OFF. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10216684 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140454. One submission often covers many models, so check the product and lot details in each record.

• Z-2363-2023 · Jul 12, 2023 · Open, Classified
  CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K