CD HORIZON® Spinal System 7570905Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994302755), received between Feb 23, 2018 and May 15, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT WHO HAD VERTEBRAL FR ACTURE DUE TO MOTOR VEHICLE ACCIDENT. IT WAS REPORTED THAT THE EXTENDER WON¿T LET THE SCREWDRIVER GO DOWN THE SHAFT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2025 MAY 6, UPDATE RECEIVED: THE SCREWDRIVER DOES NOT FIT DOWN THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024993 ↗
• InjuryMay 2, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE EXTENDER AND SLEEVES DOES NOT HOLD THE SCREW. THE EXTERNAL SLEEVE OF THE LONGITUDE SYSTEM WITHOUT PROPER PRESSURE, TIGHTENING AND/OR TORQUE FOR FITTING THE PEDICLE SCREW. INNER SLEEVE OF THE LONGITUDE SYSTEM DILATED WITHOUT PROPER PRESSURE, TIGHTENING AND/OR TOUCH TO FIT THE PEDICLE SCREW, THE SCREW WAS LOOSE IN THE ASSEMBLED DEVICE, AND RISK OF THE SCREW ESCAPING AND TO FINALIZE THE PROPOSED SURGICAL TECHNIQUE. LONGITUDE SYSTEM DULY TESTED IN PRE-SURGERY AND INTERNAL OPERATIONAL PROCEDURES. HOWEVER, DURING THE INTRAOPERATIVE PERIOD, IT WAS IDENTIFIED THAT THE PRESSURE SUFFERED IN THE SURGICAL CAVITY CAUSED THE TOWERS TO DILATE IN ORDER TO SUPPORT THE LOAD OF THE PEDICLE SCREWS AND THE BIOMECHANICAL FORCE REQUIRED TO ASSEMBLE THE SYSTEM, WHICH LED THE SURGEON TO CHANGE THE SURGICAL STRATEGY DURING THE INTRAOPERATIVE PERIOD WITHOUT HARMING THE PATIENT. PROCEDURE WAS CHANGED FROM MINIMALLY INVASIVE SURGERY TO OPEN TECHNIQUE. NO PATIENT SYMPTOMS REPORTED, NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227705 ↗
• InjuryMay 2, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE EXTENDER AND SLEEVES DOES NOT HOLD THE SCREW. THE EXTERNAL SLEEVE OF THE LONGITUDE SYSTEM WITHOUT PROPER PRESSURE, TIGHTENING AND/OR TORQUE FOR FITTING THE PEDICLE SCREW. INNER SLEEVE OF THE LONGITUDE SYSTEM DILATED WITHOUT PROPER PRESSURE, TIGHTENING AND/OR TOUCH TO FIT THE PEDICLE SCREW, THE SCREW WAS LOOSE IN THE ASSEMBLED DEVICE, AND RISK OF THE SCREW ESCAPING AND TO FINALIZE THE PROPOSED SURGICAL TECHNIQUE. LONGITUDE SYSTEM DULY TESTED IN PRE-SURGERY AND INTERNAL OPERATIONAL PROCEDURES. HOWEVER, DURING THE INTRAOPERATIVE PERIOD, IT WAS IDENTIFIED THAT THE PRESSURE SUFFERED IN THE SURGICAL CAVITY CAUSED THE TOWERS TO DILATE IN ORDER TO SUPPORT THE LOAD OF THE PEDICLE SCREWS AND THE BIOMECHANICAL FORCE REQUIRED TO ASSEMBLE THE SYSTEM, WHICH LED THE SURGEON TO CHANGE THE SURGICAL STRATEGY DURING THE INTRAOPERATIVE PERIOD WITHOUT HARMING THE PATIENT. PROCEDURE WAS CHANGED FROM MINIMALLY INVASIVE SURGERY TO OPEN TECHNIQUE. NO PATIENT SYMPTOMS REPORTED, NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227696 ↗
• InjuryMay 2, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE EXTENDER AND SLEEVES DOES NOT HOLD THE SCREW. THE EXTERNAL SLEEVE OF THE LONGITUDE SYSTEM WITHOUT PROPER PRESSURE, TIGHTENING AND/OR TORQUE FOR FITTING THE PEDICLE SCREW. INNER SLEEVE OF THE LONGITUDE SYSTEM DILATED WITHOUT PROPER PRESSURE, TIGHTENING AND/OR TOUCH TO FIT THE PEDICLE SCREW, THE SCREW WAS LOOSE IN THE ASSEMBLED DEVICE, AND RISK OF THE SCREW ESCAPING AND TO FINALIZE THE PROPOSED SURGICAL TECHNIQUE. LONGITUDE SYSTEM DULY TESTED IN PRE-SURGERY AND INTERNAL OPERATIONAL PROCEDURES. HOWEVER, DURING THE INTRAOPERATIVE PERIOD, IT WAS IDENTIFIED THAT THE PRESSURE SUFFERED IN THE SURGICAL CAVITY CAUSED THE TOWERS TO DILATE IN ORDER TO SUPPORT THE LOAD OF THE PEDICLE SCREWS AND THE BIOMECHANICAL FORCE REQUIRED TO ASSEMBLE THE SYSTEM, WHICH LED THE SURGEON TO CHANGE THE SURGICAL STRATEGY DURING THE INTRAOPERATIVE PERIOD WITHOUT HARMING THE PATIENT. PROCEDURE WAS CHANGED FROM MINIMALLY INVASIVE SURGERY TO OPEN TECHNIQUE. NO PATIENT SYMPTOMS REPORTED, NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227671 ↗
• MalfunctionDec 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR ARTHRODESIS SURGERY DUE TO SPINE PAIN. INTRA-OP, THE INSTRUMENT WAS DAMAGED, SO THE SCREW DID NOT FIT PROPERLY. THE PART OF THE INSTRUMENT THAT FITS THE SCREW WAS BENT, WHICH DID NOT ALLOW THE PERFECT FIT OF THE SAME, MAKING THE IMPLANTATION IN THE PATIENT UNFEASIBLE. NO ANY FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9528859 ↗
• MalfunctionFeb 23, 2018Bent; Bent

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT MINIMALLY INVASIVE LUMBAR DECOMPRESSION AND FUSION AT L3-S1. DURING SURGERY, THE SLEEVES EACH ¿POPPED¿ OFF WHEN SURGEON WAS ATTEMPTING TO REDUCE ROD INTO SCREW HEAD. THE SLEEVES APPEAR BENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7291593 ↗
• MalfunctionFeb 23, 2018Bent; Bent

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT MINIMALLY INVASIVE LUMBAR DECOMPRESSION AND FUSION AT L3-S1. DURING SURGERY, THE SLEEVES EACH ¿POPPED¿ OFF WHEN SURGEON WAS ATTEMPTING TO REDUCE ROD INTO SCREW HEAD. THE SLEEVES APPEAR BENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7291592 ↗
• MalfunctionFeb 23, 2018Bent; Bent

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT MINIMALLY INVASIVE LUMBAR DECOMPRESSION AND FUSION AT L3-S1. DURING SURGERY, THE SLEEVES EACH ¿POPPED¿ OFF WHEN SURGEON WAS ATTEMPTING TO REDUCE ROD INTO SCREW HEAD. THE SLEEVES APPEAR BENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7291589 ↗