CD Horizon® Spinal System 55740007545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994996107), received between Jan 13, 2021 and Jan 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN L3/4/5 O BLIQUE LATERAL INTERBODY FUSION (OLIF), L5/S TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), POSTERIOR FIXATION OF T9-S2AI FOR THORACOLUMBAR KYPHOSIS. LEVELS IMPLANTED WAS T9-S2AI. IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSE SCREWS. AFTER PERFORMING L3/4 OLIF AND INSERTING THE CAGE AT L4/5, AN ATTEMPT WAS MADE TO REMOVE THE INSERTER, BUT THE CENTRAL SHAFT REMAINED AND WAS RECONNECTED TO THE INSERTER, BUT IT COULD NOT BE SECURED AND WAS UNUSABLE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE INSERTER WAS BROKEN. THERE WAS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090233 ↗
• InjuryAug 26, 2024Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR (DIS), HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN REPLACEMENT OF L5 LEFT SCREW FOR LUMBAR DEGENERATIVE SPONDYLOLISTHESIS, SPINAL CANAL STENOSIS IT WAS REPORTED THAT THE PATIENT HAD A RIGHT-SIDED PARALYSIS. AFTER THE PROCEDURE, PARALYSIS OCCURRED IN THE LEFT LEG; WHEN A CT SCAN WAS TAKEN, THE SCREW WAS FACING INWARDS AND WAS TOUCHING THE ROOT AND HENCE LEFT SCREW OF L5 WAS REMOVED. THE ORIENTATION WAS CHANGED AND WAS INSERTED. THERE WERE NO FURTHER COMPLICATIONS WERE REPORTED. ON (B)(6) 2024 _ARED (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THIS REVISION SURGERY WAS DUE TO SCREW FACING INWARDS AND WAS TOUCHING THE ROOT WHICH WAS CAUSED BY USER'S TECHNICAL ERROR. THERE IS NO ALLEGATION ASSOCIATED WITH THE CROSSLINK. IT WAS NOT USED IN THE FIRST SURGERY, WHEN THE SCREW WAS REPLACED, THE CROSSLINK WAS SET ACCORDING TO THE REQUEST TO SET FOR REINFORCEMENT.

  Patient problems: Paralysis

  MAUDE report 20064556 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF. IT WAS RE PORTED THAT THE PEDICLE OF THE VERTEBRAL ARCH WAS CUT OUT DURING SCREW INSERTION. VERTEBRAL ROOT CUT-OUT OCCURRED. IT WAS CHANGED TO A LARGER CANNULATED SIZE FOR RECOVERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Nerve Damage

  MAUDE report 17972201 ↗
• InjuryJan 13, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH REVISION SURGERY. IT WAS REPORTED THAT THE INITIAL SURGERY WAS DONE ON (B)(6) 2018 FOR POSTERIOR SPINAL FIXATION AFTER OLIF AT L2 / 3, L3 / 4, L4 / 5 AND ON (B)(6) 2018 T9-S2AI PSF+L5/S:PLIF. SO56+BA+CAPSTONE CONTROL+GC WERE USED IN THE INITIAL SURGERY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS KYPHOSIS. THE PATIENT HAD BACK PAIN AND THE ROD WAS BROKEN BETWEEN L3 / 4. REVISION SURGERY WAS PERFORMED TO REPLACE ROD AND SCREW. NO FRAGMENTS WERE LEFT IN PATIENT BODY. NO FURTHER COMPLICATIONS REPORTED. THE SCREW WAS LOOSENED

  Patient problems: Pain

  MAUDE report 11167017 ↗