CD HORIZON® Spinal System 7570901Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994302762), received between Feb 23, 2018 and Apr 17, 2025 — classified as 1 injury, 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854070 ↗
• 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 19227659 ↗
• MalfunctionJun 3, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT INTRA-OP, THE EXTENDER (WITH THE INNER SLEEVE INSIDE) COULD BE TURNED FORWARD ONLY TILL 'LOAD', BUT THEN IT BECAME HARD TO TURN IT FURTHER. IT COULD BE TURNED BACKWARD TO 'EJECT' BUT NOT FORWARD. DIFFERENT INNER SLEEVES WERE TRIED WITH THIS PARTICULAR EXTENDER BUT THE SAME PROBLEM OCCURRED EVERY TIME. ANOTHER EXTENDER WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662045 ↗
• MalfunctionOct 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE SCOLIOSIS AND UNDERWENT 3 LEVEL MINIMALLY INVASIVE SURGERY (MIS) OLIF(OBLIQUE LUMBAR INTERBODY FUSION) FUSION PROCEDURE AT L3 TO L5. DURING SURGERY, THE EXTENDER LOOSENED DURING ROD INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018191 ↗
• MalfunctionFeb 23, 2018Detachment Of Device Component; Detachment Of Device Component

  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 EXTENDERS REPEATEDLY POP OFF THE HEADS OF THE IMPLANTED SCREWS WHILE THE ATTEMPTED TO REDUCE THE ROD INTO THE HEAD OF THE SCREWS. WHEN TRIED TO USE THE LONG ROD REDUCER FROM THE LEGACY INSTRUMENT SET TO REDUCE ROD AND A SCREW FELL OUT OF THE HANDLE ON THE INSTRUMENT. 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 7291587 ↗