CD HORIZON® Spinal System NAV2024 (UDI 00643169693821)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169693821), received between Jun 8, 2017 and Apr 25, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE HAS 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 21907449 ↗
• MalfunctionMar 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION WITH PEDICLE SCREW IMPLANTATION THERAPY FOR LUMBAR STENOSIS. LEVELS IMPLANTED WERE L3-S1. IT WAS REPORTED THAT THE DOCTOR WAS TRYING TO IMPLANT PEDICLE SCREWS IN TO THE PATIENT ENCOUNTERED AN ISSUE WHERE THE TIPS OF BOTH SCREWDRIVERS BROKE OFF IN THE DENSE BONE. HOWEVER, THE BROKEN TIPS WERE SUCCESSFULLY REMOVED, ALLOWING THE SURGERY TO CONTINUE WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650188 ↗
• MalfunctionJan 9, 2025Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT TIP WAS WORN OUT FROM NORMAL USAGE. TIP WAS STRIPPED OUT AND WONT PROPERLY FIT INTO ANY SCREWS. 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 21109107 ↗
• MalfunctionDec 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH T10-S1 PLF THERAPY. IT WAS REPORTED THAT THE SURGEON WAS SCREWING IN A PEDICLE SCREW, PATIENT HAD REALLY HARD BONE AND THE VERY TIP OF THE SCREWDRIVER BROKE OFF. 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 18407329 ↗
• MalfunctionDec 10, 2021Break; Break

  PRE-OP DIAGNOSIS - ADJACENT SEGMENT STENOSIS, NEUROGENIC CLAUDICATION AND RADICULOPATHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974057 ↗
• MalfunctionApr 30, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION/TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1. INTRA OP, TIP OF THE DRIVER TORQUED AND WAS DAMAGED. A NEW DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014926 ↗
• MalfunctionMar 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISC HERNIATION AT L5-S1 WITH REMOVAL OF HARDWARE AND FUSION FROM L4-S1; AND UNDERWENT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION. INTRA-OP, TIP OF THE DRIVER BROKE WHILE IMPLANTING A SCREW. THE BROKEN OFF PART WAS FOUND AND REMOVED FROM THE PATIENT. NO FRAGMENT OF THE ALLEGED INSTRUMENT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772674 ↗
• MalfunctionJan 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AT SACROILIAC AND THORACOLUMBAR REGION. INTRA-OP, HEAD OF THE DRIVER BROKE OFF IN THE SCREW. THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611616 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REVISION SURGERY AT LEVEL 3 DUE TO VERTEBRAL BODY INFECTION. INTRA-OP, TIP OF THE DRIVER FRACTURED WHEN TRYING TO REMOVE A SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721119 ↗
• InjuryJun 8, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS PRE-OPERATIVE DIAGNOSED WITH SPINAL FRACTURE AND UNDERWENT S2 SACRAL ILIAC TRAJECTORY WITH THE TORQUE MULTIPLIER. INTRA-OP, THE TIP OF THE SCREW DRIVER BROKE. TIP OF SCREW DRIVER COULD NOT BE RECOVERED FROM THE HEAD OF SCREW. HENCE, THE TIP OF THE DRIVER WAS LEFT INSIDE THE PATIENT AND THIS DID NOT IMPACT THE FINAL TIGHTENING OF THE CONSTRUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6621248 ↗

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