CD HORIZON® Spinal System 70460500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994156617), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2019Connection Problem; Connection Problem

  PRE-OP DIAGNOSIS: ADULT DEFORMITY LEVELS INVOLVED: PELVIS IT WAS REPORTED THAT INTRA-OPERATIVELY, THREADS IN THE SCREW HEAD WAS NOTED TO BE STRANGE. DURING THE SURGERY, WHEN THE SCREW WAS PLACED IN THE USUAL FASHION, UPON ATTEMPTING TO INSERT A SET SCREW, THE SET SCREW WOULD NOT ENGAGE. THE SURGEON ATTEMPTED TO USE A DIFFERENT SET SCREW BUT ENCOUNTERED THE SAME RESULT. AT THAT POINT THE SURGEON CHOSE TO REMOVE THE SCREW AND INSPECT, UPON VISUAL INSPECTION HE NOTED THAT THE THREADS INSIDE THE HEAD OF THE SCREW LOOKED STRANGE. THE SCREW WAS THEN SET ASIDE AND ANOTHER SCREW WAS IMPLANTED. THE SET SCREW WOULD NOT ENGAGE TO ALTHOUGH THREADS WERE PRESENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. BREAKAGE OF PRODUCT WAS NOT OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721116 ↗