CD HORIZON® Spinal System X0212549Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169607095), received between May 30, 2022 and May 30, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2022Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL STENOSIS. PROCEDURE OR TECHNIQUE USED WAS OPEN PLF. LEVELS IMPLANTED L3-5. IT WAS REPORTED THAT AFTER IMPLANTING THE SCREWS, SURGEON TRIED TO SEAT THE RODS. TWO HEADS OF THE SCREWS WERE NOT ROTATING. AFTER BACKING THE SCREWS OUT SLIGHTLY (ABOUT A HALF TO A FULL TURN) TO GET THE POLYAXIAL HEAD TO LOOSEN SO IT COULD ROTATE ENOUGH TO SEAT THE ROD. HOWEVER AFTER DOING THAT WITH EACH SCREW, THE TWO SCREW HEADS WERE STILL ONLY MOVING CEPHALAD/ CAUDAL. SO SURGEON REMOVED EACH SCREW AND RE-IMPLANTED WITH TWO LONGER SCREWS (6.5X45). THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE SCREW WOULDN¿T MOVE MEDIAL/LATERAL BUT OTHER THAN THAT NO REAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539297 ↗
• MalfunctionMay 30, 2022Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL STENOSIS. PROCEDURE OR TECHNIQUE USED WAS OPEN PLF. LEVELS IMPLANTED L3-5. IT WAS REPORTED THAT AFTER IMPLANTING THE SCREWS, SURGEON TRIED TO SEAT THE RODS. TWO HEADS OF THE SCREWS WERE NOT ROTATING. AFTER BACKING THE SCREWS OUT SLIGHTLY (ABOUT A HALF TO A FULL TURN) TO GET THE POLYAXIAL HEAD TO LOOSEN SO IT COULD ROTATE ENOUGH TO SEAT THE ROD. HOWEVER AFTER DOING THAT WITH EACH SCREW, THE TWO SCREW HEADS WERE STILL ONLY MOVING CEPHALAD/ CAUDAL. SO SURGEON REMOVED EACH SCREW AND RE-IMPLANTED WITH TWO LONGER SCREWS (6.5X45). THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE SCREW WOULDN¿T MOVE MEDIAL/LATERAL BUT OTHER THAN THAT NO REAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539295 ↗