CD HORIZON® Spinal System 8115558Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00721902729782), received between May 8, 2017 and Apr 19, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionApr 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR SPINAL FUSION. IT WAS REPORTED THAT DURING FINAL TIGHTENING OF CROSSLINK ONE OUTER SET SCREW ON ROD SHEARED OFF BELOW THE NORMAL SHEAR POINT, LEAVING A SMALL CONICAL PIECE OF THE LEADING EDGE OF THE CROSSLINK SET SCREW AND NO PURCHASE TO THE ROD. AT THIS POINT THERE WAS NO ABILITY TO REMOVE THE IMPROPERLY TIGHTENED SET SCREW SO THE RODS HAD TO BE REMOVED TO REMOVE THE CROSSLINK FROM THE PATIENT. NEW RODS WERE PLACED WITHOUT A CROSSLINK. 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 14140888 ↗
• MalfunctionMar 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR DEGENERATION; AND UNDERWENT POSTERIOR LUMBAR DECOMPRESSION AND FUSION. INTRA-OP, THE ALLEGED IMPLANT BROKE. THE BROKEN IMPLANT WAS THEN COMPLETELY EXPLANTED WITH NO BROKEN FRAGMENTS REMAINING INSIDE THE PATIENT. THE BROKEN PRODUCT WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9863799 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LUMBAR DEGENERATION; AND UNDERWENT LUMBAR INTERNAL FIXATION. INTRA-OP, THE CROSSLINK PLATE BROKE. THE BROKEN PLATE WAS COMPLETELY EXPLANTED FROM THE PATIENT. NO FRAGMENTS OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8076977 ↗
• MalfunctionMay 8, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SET SCREW OF THE CROSSLINK BROKE IN THE MIDDLE. THEN THE CROSSLINK WAS CHANGED WITH ANOTHER ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6550908 ↗